Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry

Administrative draft guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

Product Title and Initial U.S.
Approval in the Highlights of
Prescribing Information for Human
Prescription Drug and Biological
Products — Content and Format
Guidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit electronic comments to https://www.regulations.gov. Submit written
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the
docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document, contact (CDER) Debra Beitzell at (301) 796-0900,
or (CBER) the Office of Communication, Outreach, and Development at 800-835-4709 or 240-
402-8010.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
January 2018
Labeling
10253dft.docx
12/15/17

Product Title and Initial U.S.
Approval in the Highlights of
Prescribing Information for Human
Prescription Drug and Biological
Products — Content and Format
Guidance for Industry
Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353; Email: druginfo@fda.hhs.gov
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
and/or
Office of Communication, Outreach, and Development
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Food and Drug Administration
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Silver Spring, MD 20993-0002
Phone: 800-835-4709 or 240-402-8010; Email: ocod@fda.hhs.gov
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
January 2018
Labeling

TABLE OF CONTENTS
I. 	INTRODUCTION............................................................................................................. 1
II. 	BACKGROUND ............................................................................................................... 2
III. 	SOURCES FOR PRODUCT TITLE TERMINOLOGY .............................................. 3
A. 	Drug Names .................................................................................................................................... 3
1. Proprietary Name ............................................................................................................................ 3
2. Nonproprietary Name ...................................................................................................................... 3
a. 	Nonproprietary name of drug products approved under the Federal Food, Drug, and
Cosmetic Act ............................................................................................................................. 3
b. 	Nonproprietary name of biological products licensed under the Public Health Service Act .... 4
B. 	Dosage Form................................................................................................................................... 4
C. 	Route of Administration................................................................................................................ 4
D. 	Controlled Substance Symbol....................................................................................................... 5
IV. 	PRODUCT TITLE CONTENT AND FORMAT .......................................................... 5
A. 	Basic Format .................................................................................................................................. 5
B. 	Drug Names .................................................................................................................................... 6
1. General Format ............................................................................................................................... 6
a. 	Display of the proprietary name ................................................................................................ 6
b. 	Display of the nonproprietary name for nonbiological drug products ...................................... 6
c. 	Display of the nonproprietary (proper) name for biological products ...................................... 6
d. 	Special considerations for nonproprietary names of drug products that contain a salt ............. 7
2. Fixed-Combination Drug Products ................................................................................................. 7
3. Drug Products Without Proprietary Names .................................................................................... 7
C. 	Dosage Form................................................................................................................................... 8
1. General Format ............................................................................................................................... 8
2. Multiple Dosage Forms ................................................................................................................... 8
3. Dosage Form Descriptors................................................................................................................ 8
4. Drug Products Requiring Reconstitution......................................................................................... 9
5. Injectable Drug Products................................................................................................................. 9
6. Drug Delivery Systems..................................................................................................................... 9
D. 	Route of Administration.............................................................................................................. 10
1. General Format ............................................................................................................................. 10
2. Injectable Drug Products............................................................................................................... 10
3. Multiple Routes of Administration ................................................................................................. 11
4. Intravenous Methods...................................................................................................................... 11
5. Inhaled Drug Products .................................................................................................................. 11
E. 	Drug Products With Special Nomenclature Considerations .................................................... 11
1. Infusion Solutions .......................................................................................................................... 11
2. Co-Packaged Drug Products ......................................................................................................... 12
3. Lipid Complexes ............................................................................................................................ 13
4. Liposomes ...................................................................................................................................... 14
5. Radiopharmaceuticals ................................................................................................................... 14
a. 	General format ........................................................................................................................ 14
i

b. 	Radionuclide generator and associated drug product nomenclature ....................................... 15
F. 	Controlled Substance Symbol..................................................................................................... 16
V. 	ITEMS THAT SHOULD NOT BE INCLUDED IN THE PRODUCT TITLE ........ 17
VI. 	PRODUCT TITLE AND IMPLICATIONS FOR CONTAINER AND CARTON
LABELING ..................................................................................................................... 18
VII. 	INITIAL U.S. APPROVAL ........................................................................................... 19
A. 	Active Moiety................................................................................................................................ 19
B. 	Multiple Dosage Forms................................................................................................................ 19
C. 	Fixed-Combination Drug Products and Co-Packaged Drug Products ................................... 20
D. 	Controlled Substances ................................................................................................................. 20
E. 	Racemates ..................................................................................................................................... 20
F. 	Drug Efficacy Study Implementation Drugs ............................................................................. 21
G. 	Approval of Previous Marketed Unapproved Drugs................................................................ 21
H. 	Previously Approved Drug Product Reintroduced Into Market ............................................. 21
GLOSSARY................................................................................................................................. 22
APPENDIX A: DOSAGE FORM TERMS FOR USE IN HUMAN DRUG PRODUCT
LABELING ................................................................................................................................. 24
APPENDIX B: ROUTE OF ADMINISTRATION TERMS FOR USE IN THE
PRODUCT TITLE...................................................................................................................... 36
ii

Contains Nonbinding Recommendations
Draft – Not for Implementation
1 	Product Title and Initial U.S. Approval in the Highlights of
2 	Prescribing Information for Human Prescription Drug and
3 	Biological Products — Content and Format
4 	Guidance for Industry1
5
6
7
8
9 	This draft guidance, when finalized, will represent the current thinking of the Food and Drug
10 	Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not
11 	binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the
12 	applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible
13 	for this guidance as listed on the title page.
14
15
16
17
18 	I. 	INTRODUCTION
19
20 	This guidance is intended to assist applicants in complying with certain labeling requirements for
21 	human prescription drug and biological products (21 CFR 201.56 and 201.57). 2 This guidance
22 	provides recommendations for applicants developing labeling for new drugs and revising
23 	labeling for already approved drugs. Specifically, this guidance provides recommendations on
24 	the content and format of the product title (21 CFR 201.57(a)(2))3 and initial U.S. approval
25 	(21 CFR 201.57(a)(3)) lines in the Highlights of Prescribing Information (Highlights) as
26 	described in 21 CFR 201.57(a). This guidance provides recommendations on the content and
27 	format of the product title and year of initial U.S. approval to bring greater consistency to the
28 	presentation of these required elements in labeling and to help ensure these elements provide
29 	clear and useful information to the reader.
1 This guidance has been prepared by the Office of New Drugs in the Center for Drug Evaluation and Research in
cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration.
2 For purposes of this guidance, unless otherwise specified, references to drugs and drug products include drugs
approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and biological products licensed under the
Public Health Service Act (PHS Act), other than devices regulated under a biologics license application.
3 For purposes of this guidance, product title is defined as those elements required in 21 CFR 201.57(a)(2) (i.e., drug
name(s), dosage form, route of administration, and, if applicable, controlled substance symbol). See the guidance
for industry Labeling for Human Prescription Drug and Biological Products — Implementing the PLR Content and
Format Requirements. There are also numerous other FDA guidances that address labeling, including prescription
drug labeling, at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065010.htm. We update
guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs
guidance web page at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
1

Contains Nonbinding Recommendations
Draft – Not for Implementation
30
31 	The recommendations in this guidance apply only to the product title and initial U.S. approval in
32 	Highlights and do not apply to other parts of the prescribing information, or other types of
33 	labeling (e.g., container and carton labeling). The recommendations in this guidance generally
34 	are applicable to biological products (see the Glossary) licensed under the Public Health Service
35 	Act (PHS Act), but for some biological products (e.g., vaccines, blood products, allergenic
36 	extracts, or cellular and gene therapy products) other approaches may be more appropriate
37 	because of those biological products’ special characteristics. Applicants for these products
38 	should contact the applicable review division to discuss appropriate alternative approaches for
39 	complying with 21 CFR 201.57(a)(2).
40
41 	Lists of dosage form and route of administration terms have been created to assist the reader in
42 	selecting proper terminology for use in the product title and other human drug product labeling.4
43 	These lists are provided in Appendix A, Dosage Form Terms for Use in Human Drug Product
44 	Labeling, and Appendix B, Route of Administration Terms for Use in the Product Title. These
45 	appendixes will be updated as needed to add new or to revise existing terminology.
46
47 	In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
48 	Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
49 	as recommendations, unless specific regulatory or statutory requirements are cited. The use of
50 	the word should in Agency guidances means that something is suggested or recommended, but
51 	not required.
52
53
54 	II. 	BACKGROUND
55
56 	In January 2006, the FDA published a final rule amending the requirements for the content and
57 	format of labeling for human prescription drug and biological products.5 This rule is commonly
58 	referred to as the physician labeling rule because it addresses prescription drug labeling that is
59 	used by physicians and other health care providers.
60
2
4 The FDA identifies a list of drug products approved on the basis of safety and effectiveness in its publication
“Approved Drug Products With Therapeutic Equivalence Evaluations,” commonly referred to as the Orange Book.
The Orange Book uses uniform terms to designate dosage forms and routes of administration (those terms are listed
in Appendix C of the Orange Book). To the extent that there are differences between the dosage forms and routes of
administration provided in this guidance and its appendixes and those listed in the current edition of the Orange
Book, the Orange Book terms should be consulted for the purposes of section 505(j) of the FD&C Act and the
FDA’s implementing regulations (e.g., when determining whether drug products have the same dosage form and
route of administration). Additionally, this guidance is not intended to be used in determining what constitutes a
separate marketing application for assessing user fees (see the guidance for industry Submitting Separate Marketing
Applications and Clinical Data for Purposes of Assessing User Fees for details).
5 See the final rule “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological
Products” (71 FR 3922, January 24, 2006).

Contains Nonbinding Recommendations
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61 	Under this rule, prescription labeling must contain three sections: Highlights, Full Prescribing
62 	Information: Contents, and Full Prescribing Information (21 CFR 201.56(d)(1)). Highlights
63 	must contain the drug’s proprietary name,6 nonproprietary name7 together with any appropriate
64 	descriptors, dosage form, route of administration, and the controlled substance symbol, if
65 	applicable (21 CFR 201.57(a)(2)). This information follows the Highlights Limitation Statement
66 	(21 CFR 201.57(a)(1)) and is referred to as the product title in this guidance. Additionally,
67 	Highlights must include the year of the initial U.S. approval, which must be placed directly
68 	underneath the product title (21 CFR 201.57(a)(3)).
69
70
71 	III. 	SOURCES FOR PRODUCT TITLE TERMINOLOGY
72
73 	A. 	Drug Names
74
75 	1. 	Proprietary Name
76
77 	The proprietary name is the exclusive name of a drug product owned by a company under
78 	trademark law regardless of registration status with the U.S. Patent and Trademark Office.
79
80 	2. 	Nonproprietary Name
81
82 	a. 	Nonproprietary name of drug products approved under the Federal Food,
83 	Drug, and Cosmetic Act
84
85 	The nonproprietary name of a drug product approved under the Federal Food, Drug, and
86 	Cosmetic Act (FD&C Act) is its established name (see the Glossary), which ordinarily will be
87 	the United States Pharmacopeia (USP) drug product monograph title for that drug product.8 If
88 	there is no USP monograph for the drug product under review, then the applicant should refer to
89 	21 CFR 299.4(e) (addressing established names for drugs) and the USP nomenclature guidelines
90 	as set forth in the USP General Chapter <1121> Nomenclature for guidance.9
91
6 For purposes of this guidance, proprietary name refers to both the proprietary name of a drug product and to the
trade name of a biological product (see the Glossary). The FDA recognizes that not all products have a proprietary
name.
7 For purposes of this guidance, nonproprietary name refers to both the established name of a drug product and to
the proper name of a biological product except where indicated (see the Glossary).
8 See section 502(e)(3) of the FD&C Act; 21 CFR 299.4.
9 According to the USP Nomenclature Guidelines (http://www.usp.org) that are referenced in General Chapter
<1121>, the general format for a drug product monograph title is [DRUG][ROUTE OF
ADMINISTRATION][DOSAGE FORM]. Early identification of unique considerations for any of the three
components of the monograph title for a drug product is important.
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Contains Nonbinding Recommendations
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92 	b. 	Nonproprietary name of biological products licensed under the Public
93 	Health Service Act
94
95 	For biological products licensed under the PHS Act, the nonproprietary name of the product that
96 	is to appear in the product title is the product’s proper name, which is the name designated in the
97 	license for use upon each package of the product.10
98
99 	B. 	Dosage Form
100
101 	Applicants should refer to the USP as the source for dosage form terminology for use in the
102 	nonproprietary name portion of the product title in Highlights.11 Currently, this information is
103 	located in General Chapters <1151> Pharmaceutical Dosage Forms, <5> Inhalation and Nasal
104 	Drug Products — General Information and Quality Tests, and <1121> Nomenclature. The
105 	existing USP monograph titles for specific drug products also can be used as examples of
106 	appropriate dosage form terminology because, in some cases, the monographs for a new dosage
107 	form become official before incorporation of that new dosage form in one of the previously
108 	mentioned General Chapters.12 See Appendix A for a list of commonly used dosage form terms.
109 	This list was developed using information obtained from the USP General Chapters and
110 	monographs. In addition, it includes FDA-recommended terms that have not yet received full
111 	endorsement by the USP. To assist the reader, older dosage form terms that are no longer used
112 	have been included on the list along with references to currently accepted terminology. If an
113 	applicant determines that a term different from any of the examples is appropriate, the applicant
114 	is encouraged to initiate discussions with the FDA as soon as possible.
115
116 	The FDA Data Standards Manual (DSM) should not be used to select terminology for the dosage
117 	form of a drug product. The DSM often uses more specific dosage form terminology than is
118 	recommended for product title purposes.
119
120 	C. 	Route of Administration
121
122 	When the nonproprietary name does not include the route of administration, a route of
123 	administration must be added to the product title in Highlights (21 CFR 201.57(a)(2)) (see
124 	section IV.D, Route of Administration). Appendix B lists the most commonly used route of
4
10 See 21 CFR 600.3(k).
11 When there is an applicable USP monograph title for the drug product, applicants must use the monograph title as
the source for dosage form terminology for use in the nonproprietary name portion of the product title in Highlights
(section 502(e) of the FD&C Act).
12 Knowledge of the history of USP monographs is important when selecting which monograph titles to use as
models. USP notes in the USP Nomenclature Guidelines (http://www.usp.org) that are referenced in General
Chapter <1121> that some existing monograph titles do not conform to the formats outlined in <1121> because the
monograph titles were adopted before the establishment of the title formats and nomenclature policies set forth in
<1121>. USP advises that such monograph titles should not be interpreted as establishing a precedent for other
monograph titles.

Contains Nonbinding Recommendations
Draft – Not for Implementation
125 	administration terms for use in the product title in Highlights.13 This list is derived from the
126 	FDA DSM Route of Administration list14 with minor differences made to create a list for use in
127 	the product title. 	If an applicant determines that a route of administration term different from
128 	any of the examples is appropriate, the applicant is encouraged to initiate discussions with the
129 	FDA.
130
131 	D. 	Controlled Substance Symbol
132
133 	The controlled substance schedule, and thus its symbol, is assigned by the Drug Enforcement
134 	Administration (DEA). As described in 21 CFR parts 1302 and 1308, a drug may be assigned to
135 	controlled substance schedule I, II, III, IV, or V.
136
137
138 	IV. 	PRODUCT TITLE CONTENT AND FORMAT
139
140 	A. 	Basic Format
141
142 	The product title must include the drug name(s) (proprietary and nonproprietary), dosage form,
143 	route of administration, and, when applicable, controlled substance symbol (21 CFR
144 	201.57(a)(2)).
145
146 	The entire product title must be in bold print (21 CFR 201.57(d)(5)). The product title should be
147 	in the same type face and font size as the rest of Highlights. The product title should be
148 	presented as continuous wrapping text to maintain consistency among all approved drug products
149 	and to preserve space in Highlights.15 Abbreviations should be avoided in the product title
150 	because they may be misread, increasing the risk of confusion or medication errors.
151
152 	It should be noted that 21 CFR 201.57(a)(2) does not include the drug product strength as part of
153 	the product title. The regulations under 21 CFR 201.57(a)(8) require that the strength appear
154 	under the Dosage Forms and Strengths heading in Highlights. Omitting strengths from the
155 	product title avoids clutter and redundancy within Highlights (see section V., Items That Should
156 	Not Be Included in the Product Title).
157
5
13 Many of the terms in Appendix B are also used when including the route of administration in the nonproprietary
name. When there is an applicable USP monograph title for the drug product, applicants must use the monograph
title as the source for route of administration terminology for use in the nonproprietary name portion of the product
title in Highlights (section 502(e) of the FD&C Act).
14
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/D
ataStandardsManualmonographs/ucm071667.htm.
15 In rare cases, such as for complex product titles, it may be preferable not to wrap the text continuously for clarity.
For example, the dosage form and route of administration could be presented on the line beneath the drug name(s).

Contains Nonbinding Recommendations
Draft – Not for Implementation
158 	B. 	Drug Names
159
160 	1. 	General Format
161
162 	a. 	Display of the proprietary name
163
164 	The proprietary name should appear in uppercase letters, regardless of how it is displayed
165 	elsewhere (e.g., on the container and carton labeling), to easily identify the drug product and
166 	distinguish it from the rest of the product title.
167
168 	b. 	Display of the nonproprietary name for nonbiological drug products
169
170
171
The nonproprietary name of a nonbiological drug product should appear in parentheses in
lowercase letters.16 The FDA recommends two options for the placement of the parentheses
172 	around the nonproprietary name. The option selected should correspond to the proprietary name
173 	that precedes it. Examples provided throughout the guidance illustrate the two different
174 	approaches, which are as follows:
175
176 	(1) If the proprietary name corresponds to a drug product available in a single dosage form,
177 	the entire nonproprietary name including the dosage form and, when applicable, the route
178 	of administration should be included in the parentheses.
179
180 	For example:
181
182 	The drug name “MYDRUG (drugozide nasal spray)” indicates that the proprietary
183 	name “MYDRUG” is assigned only to the nasal spray dosage form.
184
185 	(2) If an applicant intends to market other dosage forms of the same active ingredient (see
186
187
the Glossary) under the same proprietary name, only the reference to the chemical
component portion of the nonproprietary name should appear within the parentheses.17
188
189 	For example:
190
191 	The drug name “MYDRUG (drugozide) nasal spray” indicates that the proprietary
192 	name “MYDRUG” may be assigned to multiple dosage forms.
193
194 	c. 	Display of the nonproprietary (proper) name for biological products
195
196 	The proper names of biological products typically do not include a route of administration or
197 	dosage form. Therefore, the route of administration and/or dosage form should not be located
16 Exceptions from this approach may be appropriate for certain drug products (lipids, liposomes, and for isotope
nomenclature as described in section IV.E., Drug Products With Special Nomenclature Considerations) and for
certain accepted scientific terms (e.g., microbiologic nomenclature for a genus or serogroup).
17 For a nonbiological drug product, the name used for the chemical component (active ingredient or active moiety)
is selected based on the recommendations set forth in General Chapter <1121>.
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198 	inside the parentheses, as shown in the example in this subsection and subsequent similar
199 	examples throughout this guidance, to signify certain characteristics of a drug product.
200
201 	For example:
202
203 	MYDRUG (drugimab-cznm) injection, for subcutaneous use
204
205 	d. 	Special considerations for nonproprietary names of drug products that
206 	contain a salt
207
208 	Applicants for new salt drug products should consult the General Chapter <1121> discussion of
209 	USP’s naming policy for such drug products. Under the USP’s policy, the titles of USP
210 	monographs for drug products formulated with a salt of an acid or base typically use the name of
211 	the active moiety (e.g., “MYDRUG (drugozide) tablets, for oral use”), rather than the salt
212 	form (e.g., “MYDRUG (drugozide hydrochloride) tablets, for oral use”). There are
213
214
exceptions to this general rule if the salt conveys vital clinical information, in which case the
nonproprietary name should include the salt.18 The FDA also recommends that applicants for
215 	such drug products consult the relevant review division early in the development process for
216 	guidance on the appropriate nonproprietary name for such drug products.
217
218 	2. 	Fixed-Combination Drug Products
219
220 	For purposes of this guidance, a fixed-combination drug product is one in which two or more
221 	active ingredients are combined at a fixed dosage in a single dosage form.
222
223 	For fixed-combination drug products, the word “and” should be used to separate the active
224 	ingredients in the nonproprietary name. Slash marks (/) should be avoided because they may be
225 	misread, leading to an increased risk of confusion and medication errors.
226
227 	For example:
228
229 	MYDRUG (drugozide and drugomycin capsules), for oral use
230
231 	If there are more than two active ingredients, they should be written following the convention of
232 	a, b, and c.
233
234 	For example:
235
236 	MYDRUG (drugozide, drugomycin, and drugazole) capsules, for oral use
237
238 	3. 	Drug Products Without Proprietary Names
239
240 	If the drug product does not have a proprietary name, the chemical component portion of the
241 	nonproprietary name should appear in all uppercase letters to easily identify the subject drug and
18 See the guidance for industry Naming of Drug Products Containing Salt Drug Substances.
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242 	distinguish it from the rest of the product title, and the parentheses around the name should be
243 	omitted entirely.
244
245 	For example:
246
247 	DRUGOZIDE oral solution
248 	DRUGOZIDE tablets, for oral use
249
250 	C. 	Dosage Form
251
252 	1. 	General Format
253
254 	The dosage form should appear in all lowercase letters. The plural noun of the dosage form
255 	(e.g., lozenges) should be used unless the drug product is supplied only as a single unit (e.g.,
256 	intravitreal insert).
257
258 	2. 	Multiple Dosage Forms
259
260 	If the labeling discusses multiple dosage forms for a drug product under the same proprietary
261 	name, each dosage form should be presented on a separate line for ease of reading.
262
263 	For example:
264
265 	MYDRUG (drugozide) tablets, for oral use
266 	MYDRUG (drugozide) oral solution
267 	MYDRUG (drugozide) injection, for intravenous use
268
269 	3. 	Dosage Form Descriptors
270
271 	The descriptors extended-release and delayed-release are the only terms that should be used, if
272 	applicable, when describing a modified-release dosage form (see Appendix A).
273
274 	For example:
275
276 	MYDRUG (drugozide) delayed-release capsules, for oral use
277 	MYDRUG (drugozide) for extended-release oral suspension
278
279 	If a fixed-combination drug product contains active ingredients with a combination of release
280 	characteristics, the nomenclature of the product should be based on the following principles:
281
282 	 	A combination of immediate-release and extended-release is referred to as extended-
283 	release
284
285 	 	A combination of delayed-release and extended-release is referred to as extended-release
286
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287 	 	A combination of immediate-release and delayed-release with at least one active
288 	ingredient exhibiting both release characteristics is referred to as extended-release
289
290 	 	A combination of immediate-release and delayed-release with no active ingredient
291 	exhibiting both characteristics is referred to as delayed-release
292
293 	4. 	Drug Products Requiring Reconstitution
294
295 	The use of the word “for” before a dosage form term should be used to describe a solid dosage
296 	form (e.g., lyophilized powder or granules) that requires reconstitution before administration (see
297 	Appendix A).
298
299 	For example:
300
301 	MYDRUG (drugozide) for oral suspension
302 	MYDRUG (drugozide) for injection, for intravenous use
303
304 	5. 	Injectable Drug Products
305
306 	The dosage form injection should be used for drug products available as solutions that will be
307 	injected, regardless of whether or not they need further dilution before administration. The term
308 	injection assumes that the drug product is a solution, whereas for injection should be used when
309 	the drug product is a solid (e.g., lyophilized powder) that must be reconstituted before
310 	administration (see Appendix A).19
311
312 	For example:
313
314 	MYDRUG (drugozide injection), for intravenous use
315 	MYDRUG (drugozide) injectable suspension, for subcutaneous use
316 	MYDRUG (drugozide) for injectable suspension, for intramuscular use
317
318 	6. 	Drug Delivery Systems
319
320 	If the drug product includes a delivery system (e.g., inhaler or pen injector), the system should
321 	not be included in the nonproprietary name because the delivery system generally is not part of
322 	the dosage form of a drug product. Descriptions of delivery systems should be presented
323 	elsewhere in the labeling (e.g., in the DOSAGE AND ADMINISTRATION, DESCRIPTION,
324 	and HOW SUPPLIED/STORAGE AND HANDLING sections).
325
326 	For example:
327
328 	A drug product with a pen injector for subcutaneous administration should not include the
329 	delivery system in the product title (e.g., “MYDRUG (drugozide) injection, for
330 	subcutaneous use”).
331
19 See General Chapter <1121> for additional information on the nomenclature of injectable drug products.
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332 	The proprietary name of a delivery system can be included in the product title if it is part of the
333 	official proprietary name of the drug product, and therefore can appear with the proprietary
334 	name.
335
336 	For example:
337
338 	MYDRUG NEWHALER (drugozide) inhalation solution, for oral inhalation use
339
340 	D. 	Route of Administration
341
342 	1. 	General Format
343
344 	For most dosage forms other than tablets, capsules, and injections, the route of administration
345 	usually precedes the dosage form (see Appendix A for recommendations for dosage forms). The
346 	route of administration need not be repeated if it precedes the dosage form.
347
348 	For example:
349
350 	MYDRUG (drugozide) otic solution
351 	MYDRUG (drugozide nasal spray)
352
353 	When the dosage form is not preceded by the route of administration, the route should be
354 	presented as “for [route] use,” preceded by a comma, and should appear in all lowercase letters.
355
356 	For example:
357
358 	MYDRUG (drugozide) ointment, for topical use
359 	MYDRUG (drugozide tablets), for oral use
360
361 	Because the product title cannot address all potential safety concerns and many drug products are
362 	administered by a single route, the word “only” should not appear with the route of
363 	administration (e.g., for topical use only). However, omitting such descriptors from the product
364 	title is not intended to establish a precedent for how route of administration information should
365 	be presented elsewhere on the container and carton labeling (see section VI., Product Title and
366 	Implications for Container and Carton Labeling) and elsewhere in the prescribing information
367 	(e.g., in the DOSAGE AND ADMINISTRATION section).
368
369 	2. 	Injectable Drug Products
370
371 	When the dosage form is an injection, the route of administration should follow the dosage form,
372 	preceded by a comma. Abbreviations should be avoided in the product title because they may be
373 	misread, increasing the risk of confusion and medication errors. For example, applicants should
374 	use the words “intravenous” or “subcutaneous” instead of “IV” or “SC.”
375
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376 	For example:
377
378 	MYDRUG (drugozide) injection, for intramuscular use
379
380 	3. 	Multiple Routes of Administration
381
382 	If a drug product has more than one route of administration, the word “or” should be used to
383 	separate two routes. For more than two routes of administration, the convention of a, b, or c
384 	should be followed.
385
386 	For example:
387
388 	MYDRUG (drugozide) injection, for intramuscular, subcutaneous, or intravenous use
389
390 	4. 	Intravenous Methods
391
392 	For drugs that are administered by specific intravenous methods (e.g., intravenous push or
393 	intravenous infusion), the route of administration should remain for intravenous use because
394 	21 CFR 201.57(a)(2) does not specify methods of administration as an element of the product
395 	title. Additional descriptors of the method should be included elsewhere in labeling (e.g.,
396 	presented prominently under the Dosage and Administration heading in Highlights) to help
397 	ensure safe use of the drug. Additionally, container and carton labeling can include such
398 	descriptors (e.g., for intravenous infusion instead of for intravenous use) (see section VI.,
399 	Product Title and Implications for Container and Carton Labeling).
400
401 	5. 	Inhaled Drug Products
402
403 	Inhaled drug products are unique because the definition of the route of administration term
404 	inhalation is used for drug products approved for both oral and nasal use. Therefore, the precise
405 	inhalation route (i.e., oral inhalation, nasal inhalation, or simply inhalation if both uses are
406 	approved) should be included in the product title (see Appendix B). This is an exception to the
407 	recommendation that the route need not be repeated if it is part of the nonproprietary name (see
408 	section IV.D.1., General Format).
409
410 	For example:
411
412 	MYDRUG (drugozide) inhalation aerosol, for oral inhalation use
413 	MYDRUG (drugozide) inhalation solution, for inhalation use
414
415 	E. 	Drug Products With Special Nomenclature Considerations
416
417 	1. 	Infusion Solutions
418
419 	Premixed drug products for infusion should have nonproprietary names formatted as “[drug] in
420 	[vehicle] injection.” Examples of names of drug products for infusion as they should appear in
421 	the product title are given below.
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422
423 	For example:
424
425 	MYDRUG (drugozide in dextrose injection), for intravenous use
426 	MYDRUG (drugozide in dextrose and sodium chloride injection), for intravenous use
427
428 	Premixed drug products for infusion that do not have a proprietary name should be named using
429 	the format described under section IV.B.3., Drug Products Without Proprietary Names. For
430 	example:
431
432 	DRUGOZIDE IN DEXTROSE injection, for intravenous use
433
434 	The strength of the vehicle should not be included in the product title. However, on container
435 	and carton labeling, the strength of the vehicle(s) should be stated as if part of the nonproprietary
436 	name (e.g., 5% Dextrose Injection, or Dextrose Injection 5%; 5% Dextrose and 0.2% Sodium
437 	Chloride Injection, or Dextrose (5%) and Sodium Chloride (0.2%) Injection).
438
439 	Injectable drug products that are packaged in combination with an infusion solution in a manner
440 	that does not allow for separate use of either product and are therefore intended to be mixed
441 	together (i.e., admixed) before use should be named using the format for combination products
442 	(see section IV.B.2., Fixed-Combination Drug Products). An example of a product title for a
443 	dual chamber container that contains a lyophilized powder in one chamber and the infusion
444 	solution in another chamber is given below.
445
446 	For example:
447
448 	MYDRUG (drugozide for injection and dextrose injection), for intravenous use
449
450 	For more complicated infusion solutions (e.g., three or more drug products in a closed,
451 	multichamber container that is mixed before administration), we encourage applicants to contact
452 	FDA review staff to determine the presentation of the product title.
453
454 	2. 	Co-Packaged Drug Products
455
456 	For purposes of this guidance, a co-packaged drug product is a product that contains two or more
457 	separate drugs in their final dosage forms that are intended to be used together for a common or
458 	related therapeutic purpose and that are contained in a single package or unit.
459
460 	The dosage forms (and, if applicable as described in this guidance, the route of administration
461 	(see section IV.D., Route of Administration)) generally should appear within the nonproprietary
462 	name for clarity. Also, for such drug products, a semicolon should be used between the
463 	nonproprietary names instead of the word “and” to differentiate co-packaged drug products from
464 	fixed-combination drug products. The word “co-packaged” should appear after the
465 	nonproprietary names.
466
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467 	The route of administration should be included after the parentheses as recommended in section
468 	IV.D., Route of Administration.
469
470 	For example:
471
472 	MYDRUG (drugozide tablets; drugomycin capsules), co-packaged for oral use
473 	MYDRUG (drugozide oral solution; drugomycin tablets), co-packaged for oral use
474
475 	However, if each co-packaged drug product has the route of administration preceding the dosage
476 	form, the routes of administration need not be repeated in the product title.
477
478 	For example:
479
480 	MYDRUG (drugozide oral solution; drugomycin oral suspension), co-packaged
481 	MYDRUG (drugozide oral solution; drugomycin nasal spray), co-packaged
482
483 	If the co-packaged drug products have different routes of administration, the routes of
484 	administration should be listed in the same order in which the drug products appear within the
485 	parentheses, followed by the word “respectively” for clarity.
486
487 	For example:
488
489 	MYDRUG (drugozide injectable suspension; drugomycin tablets), co-packaged for
490 	intramuscular use and for oral use, respectively
491
492 	For more complicated co-packaged drug products (e.g., those with more than three drug
493 	products), we encourage applicants to contact FDA review staff to determine the presentation of
494 	the product title.
495
496 	For drug products for which the required diluent is enclosed in the package (e.g., a vial
497 	containing a lyophilized powder is packaged with a small vial of sterile water for injection to be
498 	used in the reconstitution of the powder), the name of the diluent generally should not be
499 	included in the product title. For purposes of this guidance, this is not considered a co-packaged
500 	drug product or an infusion solution (see section IV.E.1., Infusion Solutions).
501
502 	3. 	Lipid Complexes
503
504 	Applicants should use the general format “[drug] lipid complex type X [dosage form]” when
505 	naming a lipid complex drug product.
506
507 	Applicants should assume that the first lipid complex product approved for a particular drug and
508 	dosage form is type A, so the type should not be given (i.e., “type A” should not be included in
509 	the labeling). For subsequent drug products of the same drug and dosage form, applicants should
510 	list the type and replace “X” sequentially with B, C, D, . . . Z. For generic drugs, the name and
511 	type designation should match the reference listed drug (RLD).
512
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513 	For example:
514
515 	MYDRUG (drugozide lipid complex type B injection), for intravenous use
516
517 	4. 	Liposomes
518
519 	Applicants should use the general format “[drug] liposome type X [dosage form]” or “[drug]
520 	pegylated liposome type X [dosage form]” when naming a liposomal drug product.
521
522 	Applicants should assume that the first liposome product approved for a particular drug and
523 	dosage form is type A, so the type should not be given (i.e., “type A” should not be included in
524 	the labeling). For subsequent drug products of the same drug and dosage form, applicants should
525 	list the type and replace “X” sequentially with B, C, D, . . . Z. For generic drugs, the name and
526 	type designation should match the RLD.
527
528 	For example:
529
530 	MYDRUG (drugozide liposome type C injection), for intravenous use
531 	MYDRUG (drugozide pegylated liposome injection), for intravenous use
532
533 	5. 	Radiopharmaceuticals
534
535 	a. 	General format
536
537 	Radiopharmaceuticals are composed of two parts, a pharmaceutical and a radionuclide (isotope).
538
539
Applicants should use the general format “[drug][isotope][route of administration][dosage
form]” when naming a radiopharmaceutical drug product.20 When the drug is a salt and both
540 	parts of the salt appear in the nonproprietary name (e.g., radium chloride), the isotope should
541 	immediately follow the name of the radioactive element.
542
543 	For example:
544
545 	MYDRUG (urea C 14 capsules), for oral use
546 	MYDRUG (fludeoxyglucose F 18) injection, for intravenous use
547 	MYDRUG (radium Ra 223 chloride) injection, for intravenous use
548
549 	For radiopharmaceuticals that include a ligand, applicants should use the general nomenclature
550 	format of the radiolabeled product “[drug][isotope][ligand][route of administration][dosage
551 	form].”
552
553 	For example:
554
555 	MYDRUG (technetium Tc 99m oxidronate injection), for intravenous use
20 Because most radiopharmaceuticals are injections or capsules, the route of administration generally should not be
included in the nonproprietary name. The route of administration should follow the radiopharmaceutical name and
should be presented as described in section IV.D., Route of Administration.
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556
557 	For radiopharmaceuticals that are created using a kit that contains only a part of the active
558 	ingredient and/or for which the radionuclide is obtained from a separate source and added at the
559 	time of preparation, the name should be presented as “kit for the preparation of [product
560 	nonproprietary name].”
561
562 	For example:
563
564 	MYDRUG (kit for the preparation of technetium Tc 99m sestamibi injection), for
565 	intravenous use
566
567 	For a radiopharmaceutical that is intended for ex-vivo radiolabeling with subsequent
568 	administration of the labeled drug product, the ultimate route of administration should not be
569 	included and should be described elsewhere in labeling. Instead the phrase “for radiolabeling”
570 	should appear after the drug product name.
571
572 	For example:
573
574 	MYDRUG (indium In 111 oxyquinolone solution), for radiolabeling
575
576 	b. 	Radionuclide generator and associated drug product nomenclature
577
578 	In many cases, a generator is used to produce the radionuclide that is subsequently used as a drug
579 	product or mixed with other components to produce a drug product. In these cases, the product
580 	title should display a name for both the generator and the final drug product and include the
581 	dosage form and route of administration. The following formats should be used to create these
582 	different portions of the product title.
583
584 	 	Generator Nomenclature: When a generator is used to produce the radionuclide,
585 	applicants should use the general format “[nuclide][isotope] generator.”
586
587 	For example:
588
589 	MYDRUG (rubidium Rb 82 generator)
590
591 	 	Generated Drug Product Nomenclature: The name for the generator should be
592 	immediately followed by the phrase “to produce” and the name of the radionuclide that is
593 	produced. The salt should be included in this part of the product title when the eluting
594 	solution determines what salt is produced. Applicants should use the general format “to
595 	produce [drug][isotope].” If a salt is eluted, the placement of the cation or anion portion
596 	of the chemical name should follow standard nomenclature rules for chemical substances.
597
598 	For example:
599
600 	to produce rubidium Rb 82 chloride
601 	to produce sodium pertechnetate Tc99m
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602
603 	 	Dosage Form and Route of Administration: The dosage form and route of administration
604 	should follow the name of the produced radionuclide and be presented as described
605 	earlier in sections IV.C., Dosage Form, and IV.D., Route of Administration.
606
607 	In summary, the product title should be composed using the format “PROPRIETARY NAME
608 	([nuclide][isotope] generator) to produce [drug][isotope].”
609
610 	For example:
611
612 	MYDRUG (rubidium Rb 82 generator) to produce rubidium Rb 82 chloride injection,
613 	for intravenous use
614 	MYDRUG (technetium Tc 99m generator) to produce sodium pertechnetate Tc99m
615 	injection, for intravenous use
616
617 	F. 	Controlled Substance Symbol
618
619 	If the DEA issues an interim final rule assigning a controlled substance schedule, the controlled
620 	substance symbol must be included in the product title (21 CFR 201.57(a)(2)). The controlled
621 	substance symbol should appear at the end of the product title and be preceded by a comma. The
622 	symbol should be written as “C” followed by the Roman numeral designating the schedule. As
623 	described in 21 CFR 1302.03(c), the Roman numeral may immediately follow “C” or may be
624 	preceded by a hyphen (e.g., “CIII” or “C-III”).
625
626 	For example:
627
628 	MYDRUG (drugozide) extended-release tablets, for oral use, CIV
629 	MYDRUG (drugozide) injection, for intravenous use, C-II
630
631 	If scheduling of the controlled substance is pending when the application is approved under
632 	section 505(c) of the FD&C Act or section 351(a) of the PHS Act, the product title should reflect
633 	the pending status of the scheduling action.
634
635 	For example:
636
637 	MYDRUG (drugozide) oral solution, [controlled substance schedule pending]
638
639 	The product title must be updated with the controlled substance symbol after the DEA issues an
640 	interim final rule controlling the drug (21 CFR 201.57(a)(2)).21
641
642
21 When the DEA issues an interim final rule controlling the drug, a supplement must be submitted to reflect the
schedule (21 CFR 314.70 and 21 CFR 601.12(f)).
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643 	V. 	ITEMS THAT SHOULD NOT BE INCLUDED IN THE PRODUCT TITLE
644
645 	In the interest of consistency, the FDA discourages the following content and/or formatting from
646 	being included in the product title in Highlights:
647
648 	 	Drug product origin (e.g., synthetic, natural, or rDNA) unless it is required by regulation,
649 	it is part of the established name or proper name, or it is clinically relevant for the
650 	prescriber (e.g., human).22 (Important information on drug product origin can appear
651 	elsewhere in labeling (e.g., in the DESCRIPTION section).)
652
653 	 	Slash (/) marks when displaying the name of combination products (see section IV.B.2.,
654 	Fixed-Combination Drug Products).
655
656 	 	Additional descriptors (e.g., single-dose vial or film-coated).
657
658 	 	Methods of intravenous administration (e.g., infusion, bolus, or push) (see section
659 	IV.D.4., Intravenous Methods).
660
661 	 	Dosage strength (e.g., drugozide ointment, 0.05%) (see section IV.A., Basic Format)
662 	(exceptions may be appropriate (e.g., for intravenous immunoglobulins or albumin
663 	biological products that are available in multiple strengths)).
664
665 	 	Inactive ingredients or lack thereof (e.g., alcohol-free).
666
667 	 	Abbreviations (e.g., IV for intravenous or HCl for hydrochloride) (see section IV.A.,
668 	Basic Format).
669
670 	 	Embedded graphics (see section IV.F., Controlled Substance Symbol).
671
672 	 	Storage conditions (e.g., room temperature or frozen).
673
674 	The following words should not be used in the product title in Highlights:
675
676 	 	“USP” as part of the nonproprietary name in the product title in Highlights (as distinct
677 	from use on container or carton labeling)
678
679 	 	“Concentrate” for drug products requiring dilution before administration (see
680 	Appendix A)23
681
22 For example, 21 CFR 640.80 requires the inclusion of the word “human” for albumin biological products.
23 There are a few historical exceptions. For example, USP retains “concentrate” in Potassium Chloride for Injection
Concentrate and several other legacy drug products for various reasons.
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682 	 	“Powder” as a dosage form for drug products requiring reconstitution before
683 	administration (see section IV.C.4., Drug Products Requiring Reconstitution, section
684 	IV.C.5., Injectable Drug Products, and Appendix A)
685
686 	 	“Solution” as a dosage form for injectable drug products (see Appendix A)
687
688 	 	“Drops” as a dosage form for ophthalmic or otic suspensions and solutions (see
689 	Appendix A)
690
691 	 	“Kit” (except when the marketed drug product does not contain the active ingredient (see
692 	section IV.E.5., Radiopharmaceuticals, and Appendix A))
693
694 	 	“Only” (e.g., for topical use only) (see section IV.D.1., General Format)
695
696
697 	VI. 	PRODUCT TITLE AND IMPLICATIONS FOR CONTAINER AND CARTON
698 	LABELING
699
700 	The drug product information in the product title and on the container and carton labeling should
701 	be as consistent as possible. We acknowledge the following differences that may exist between
702 	the product title in Highlights and the container and carton labeling:
703
704 	 	The proprietary name in the product title in Highlights should be presented in uppercase
705 	letters even if the proprietary name on the container and carton labeling is presented in a
706 	different manner.
707
708 	 	The placement of the elements of the product title (e.g., controlled substance symbol)
709 	may occasionally vary between the container and carton labeling and the product title in
710 	Highlights.
711
712 	 	Although all elements of a product title in Highlights should be presented on one line as
713 	space permits, dosage form and route of administration information can be presented
714 	beneath the drug or biological product name on container and carton labeling.
715
716 	 	Abbreviations for salts (e.g., HCl for hydrochloride) are appropriate for use on container
717 	and carton labeling provided their use is consistent with USP’s labeling requirements.24
718
719 	 	Generally, the strength of the drug product does not appear in the product title in
720 	Highlights, but appears elsewhere in the prescribing information and on container and
721 	carton labeling.25
722
24 See USP General Chapter <7> Labeling for additional information on labeling of drug products.
25 For example, see 21 CFR 201.57(a)(8), 21 CFR 201.57(c)(4), 21 CFR 201.100(b)(4), 21 CFR 610.60, and
21 CFR 610.61.
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723 	 	Route of administration information may differ between the container and carton labeling
724 	and the product title in Highlights. For example:
725
726 	‒ 	When important for patient safety, the word “only” may appear with the route of
727 	administration (e.g., For topical use only) on the container and carton labeling, and
728 	elsewhere in the prescribing information, but should not be in the product title.
729
730 	‒ 	Methods of intravenous administration (e.g., intravenous infusion) may be on the
731 	container and carton labeling, but such terms should not be in the product title.
732
733
734 	VII. 	INITIAL U.S. APPROVAL
735
736 	On the line immediately beneath the product title, the verbatim statement “Initial U.S.
737 	Approval” must be displayed, followed by a colon and the four-digit year in which the FDA
738 	initially approved the new molecular entity (NME),26 the new biological product,27 or the new
739 	combination of active ingredients (21 CFR 201.57(a)(3)). The statement must be in bold print
740 	(21 CFR 201.57(d)(5)). Applicants should not list multiple years or add footnotes in Highlights
741 	regarding the year of initial U.S. approval. Applicants should consider the following items when
742 	identifying the year of the initial U.S. approval in draft labeling and should contact the FDA if
743 	other concerns arise.
744
745 	A. 	Active Moiety
746
747 	For a drug product that is not a biological product and that contains only a single active moiety
748 	(see the Glossary), the initial U.S. approval is the year in which the first drug product containing
749 	that active moiety was approved, regardless of dosage form.
750
751 	For example:
752
753 	If the active moiety drugozide was originally approved as the NME drugozide hydrochloride,
754 	any subsequent product containing drugozide (e.g., drugozide hydrobromide or drugozide as
755 	a free base) should use the year of approval of drugozide hydrochloride when selecting the
756 	year of initial U.S. approval.
757
758 	B. 	Multiple Dosage Forms
759
760 	Multiple years should not be listed for drug products with multiple dosage forms approved in
761 	different years. The initial U.S. approval should be the year of first approval of the NME, new
762 	biological product, or new combination of active ingredients regardless of dosage form, even if
19
26 In some cases, a prodrug may be considered an NME. Applicants should contact the FDA to determine if a
prodrug meets the criteria to be considered an NME for the purposes of selecting the year of initial U.S. approval.
27 For biosimilar products, see the draft guidance for industry Labeling for Biosimilar Products. When final, this
guidance will represent the FDA’s current thinking on this topic.

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763 	the labeling does not refer to the older formulation(s). Differences in indications or dosing do
764 	not affect the year of initial U.S. approval.
765
766 	C. 	Fixed-Combination Drug Products and Co-Packaged Drug Products
767
768 	For fixed-combination drug products, the novelty of the combination is the determining factor
769 	for the initial U.S. approval. For example, if a fixed-combination drug product contains
770 	components that have each been previously approved individually, then the initial U.S. approval
771 	should be the year of the approval of the combination. Likewise, if a fixed-combination drug
772 	product contains at least one component that has not previously been approved, then the initial
773 	U.S. approval should be the year of the approval of the combination, regardless of the date of
774 	approval of other previously approved components. The same approach applies to co-packaged
775 	drug products.
776
777 	D. 	Controlled Substances
778
779 	In the case of an NME, new biological product, or new combination of active ingredients for
780 	which the Department of Health and Human Services recommends controls under the Controlled
781 	Substances Act, the year of initial U.S. approval comes from the “date of approval” determined
782
783
under section 505(x) of the FD&C Act for new drug applications (NDAs) and under section
351(n) of the PHS Act for 351(a) biologics license applications (BLAs).28
784
785 	If scheduling of the controlled substance is pending when the application is approved under
786 	section 505(c) of the FD&C Act or section 351(a) of the PHS Act, the initial U.S. approval in the
787 	Highlights should reflect the pending status of the scheduling action.
788
789 	For example:
790
791 	Initial U.S. Approval: [pending controlled substance scheduling]
792
793
794
Highlights must be updated with the year of initial U.S. approval corresponding to the year in
which the DEA issues an interim final rule controlling the drug (21 CFR 201.57(a)(3)).29
795
796 	E. 	Racemates
797
798 	If a drug product is to be approved containing only one enantiomer of an already approved
799 	racemate drug product, the year for the new drug product should be that of the racemate because
800 	the individual enantiomer has already been approved as part of the racemate. The nonproprietary
801 	name of the originally approved racemate can be included in parentheses.
802
28 For affected applications approved after November 25, 2015 (the date that these subsections were added to the
respective statutory provisions), the “date of approval” is the later of: (1) the date the application is approved; or (2)
the date that the DEA issues an interim final rule controlling the drug. For applications approved before November
25, 2015, the “date of approval” is the date of the FDA approval letter for the NDA or BLA.
29 When the DEA issues an interim final rule controlling the drug, a supplement must be submitted to reflect the year
of initial U.S. approval (21 CFR 314.70 and 21 CFR 601.12(f)).
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803 	For example:
804
805 	If the drug product MYDRUG (esdrugozide) capsules is approved any time after the racemic
806 	mixture drug product’s approval in 1998, the line should read, “Initial U.S. Approval: 1998
807 	(drugozide).”
808
809 	Additional information identifying the drug product components can be included in the
810 	DESCRIPTION section of the prescribing information.
811
812 	F. 	Drug Efficacy Study Implementation Drugs
813
814 	For a drug efficacy study implementation (DESI) drug, the initial U.S. approval should be the
815 	year of the original approval of the NME, not the year of the postapproval DESI update.
816
817 	G. 	Approval of Previous Marketed Unapproved Drugs
818
819 	For marketed unapproved drugs for which an NDA is later submitted and approved, the initial
820 	U.S. approval should be the year of the first NDA approval for the “new molecular entity, new
821 	biological product, or new combination of active ingredients.”30 For marketed unapproved
822 	fixed-combination drug products, see section VII.C., Fixed-Combination Drug Products and Co-
823 	Packaged Drug Products.
824
825 	H. 	Previously Approved Drug Product Reintroduced Into Market
826
827 	When a previously approved drug product is removed from the market for any reason and
828 	subsequently reintroduced, the initial U.S. approval should be the year of the original approval of
829 	the “new molecular entity, new biological product, or new combination of active ingredients.”31
830 	For previously approved fixed-combination drug products, see section VII.C., Fixed-
831 	Combination Drug Products and Co-Packaged Drug Products
832
833
30 See 21 CFR 201.56(a)(3) .
31 See id .
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834 	GLOSSARY
835
836 	Active ingredient: An active ingredient is “any component that is intended to furnish
837 	pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or
838 	prevention of disease, or to affect the structure or any function of the body of man or other
839 	animals. The term includes those components that may undergo chemical change in the
840
841
manufacture of the drug product and be present in the drug product in a modified form intended
to furnish the specified activity or effect.”32
842
843 	Active moiety: Active moiety is “the molecule or ion, excluding those appended portions of the
844 	molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination
845
846
bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the
molecule, responsible for the physiological or pharmacological action of the drug substance.”33
847
848 	Biological product: A biological product is “a virus, therapeutic serum, toxin, antitoxin,
849 	vaccine, blood, blood component or derivative, allergenic product, protein (except any
850 	chemically synthesized polypeptide) or analogous product, or arsphenamine or derivative of
851
852
arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention,
treatment, or cure of a disease or condition of human beings.” 34
853
854 	Established name:35 As defined in the FD&C Act, “the term ‘established name,’ with respect to
855 	a drug or ingredient thereof, means (A) the applicable official name designated pursuant to
856 	section 508, or (B) if there is no such name and such drug, or such ingredient, is an article
857 	recognized in an official compendium [see definition below], then the official title thereof in
858 	such compendium, or (C) if neither clause (A) or clause (B) of this subparagraph applies, then
859 	the common or usual name, if any of such drug or such ingredient, except that where clause (B)
860 	of this subparagraph applies to an article recognized in the United States Pharmacopeia and in
861 	the Homeopathic Pharmacopoeia under different official titles, the official title used in the
862
863
United States Pharmacopeia shall apply unless it is labeled and offered for sale as a homeopathic
drug, in which case the official title used in the Homeopathic Pharmacopoeia shall apply.”36
864
865 	New molecular entity: A new molecular entity is an active ingredient that contains no active
866 	moiety that has been previously approved by the FDA in an application submitted under section
867 	505 of the FD&C Act or has been previously marketed as a drug in the United States.
868
869 	Nonproprietary name: A name unprotected by trademark rights that is in the public domain. It
870 	may be used by the public at large, both lay and professional.
32 See 21 CFR 314.3(b).
33 See 21 CFR 314.3(b).
34 See section 351(i)(1) of the PHS Act.
35 The nonproprietary name used in the product title for nonbiological drug products is the established name.
36 See section 502(e)(3) of the FD&C Act.
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871
872 	Official compendium: Official compendium is defined in the FD&C Act as “the official United
873 	States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official
874 	National Formulary, or any supplement to any of them.”37
875
876 	Product title: The product title of a drug product consists of the drug names, dosage form, route
877 	of administration, and controlled substance symbol (if applicable).38
878
879 	Proper name: For biological products, the proper name means “the name designated in the
880 	license for use upon each package of the product.”39
881
882 	Proprietary name: The exclusive name of a drug product owned by a company under
883 	trademark law regardless of registration status with the Patent and Trademark Office.
884
37 See section 201(j) of the FD&C Act.
38 See 21 CFR 201.57(a)(2).
39 See 21 CFR 600.3(k); the nonproprietary name used in the product title for biological products is the proper name.
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885 	APPENDIX A:
886 	DOSAGE FORM TERMS FOR USE IN HUMAN DRUG PRODUCT LABELING
887
888 	The following list of dosage forms has been created to assist the reader in selecting the proper
889 	dosage form terminology for use in the nomenclature of human drug products.
890
891 	The basic dosage form terms appear along the left margin. Examples of how the basic dosage
892 	form terms are used when combined with other modifiers and/or routes of administration are
893 	provided as indented text.
894
895 	 	A bolded and underlined term means both the FDA and the United States Pharmacopeia
896 	(USP) recommend use of the term
897
898 	 	A bolded term means the FDA recommends use of the term
899
900 	 	An underlined term means USP recommends use of the term
901
902 	 	A term neither bolded nor underlined means the term is a nonpreferred term
903
904 	 	Italicized examples are the subject of discussion between the FDA and USP
905
906 	Dosage form terms that appear only in bolded or underlined print are being discussed by the
907 	FDA and USP and represent terminology that may be changed at a later date. If the term is
908 	neither bolded nor underlined, then the term is a nonpreferred term and the reader is directed to
909 	preferred terminology. In some cases, USP monographs using nonpreferred terms still exist.
910 	However, these older, noncompliant terms found in monographs should not be cited as a
911 	precedent for future use of the dosage form terms.
912
913 	Indented beneath the basic dosage form term is a list of examples of how the dosage form term
914 	has been used in the nomenclature of drug products. Although an attempt has been made to
915 	make a complete list of all currently used route of administration/dosage form formats, it is
916 	recognized that new formats are created as new dosage forms or drug products with new routes
917 	of administration are developed. These examples often demonstrate how a route of
918 	administration is (or is not) used in association with the dosage form when creating a drug
919 	product nonproprietary name. There are also examples in which the dosage form includes an
920 	additional term that specifies that the release of the drug product has been modified.
921
922 	The use of the word “for” before a dosage form term is used to describe a solid dosage form
923 	(e.g., lyophilized powder or granules) that requires reconstitution before administration. The
924 	plural noun of the dosage form (e.g., lozenges) should be used unless the drug product is
925 	supplied only as a single unit (e.g., intravitreal insert).
926
927 	If an applicant determines that a format different from any of the examples is appropriate, the
928 	FDA encourages the applicant to initiate discussions with the FDA as soon as possible.
929
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930 	For biological products, applicants are encouraged to initiate discussions with the FDA on
931 	selection of dosage form terminology.
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932 	Terminology
933
934 	Aerosol
935 	Aerosols are packaged under pressure. All aerosols are assumed to be metered except topical
936 	aerosols. Topical aerosols are assumed not to be metered unless labeling indicates they are
937 	metered.
938
939 	inhalation aerosol — assumed to be for oral inhalation
940 	lingual aerosol
941 	nasal aerosol
942 	topical aerosol
943
944 	Bead — not preferred, see “Pellet”
945
946 	Caplet — not preferred, see “Tablet”
947
948 	Capsule
949 	Capsules are assumed to be oral.
950 	Note: In the past, the terminology “vaginal capsules” was used, but these drug products are
951 	now referred to as “vaginal inserts.”
952
953 	capsules
954 	delayed-release capsules
955 	extended-release capsules
956
957 	Collodion — not preferred, see “Solution”
958 	Note: Collodion is reserved for pyroxilin in alcohol and ether.
959
960 	Concentrate — not preferred term for human drug products, see the appropriate dosage form
961 	(e.g., “Solution” or “Suspension”)
962 	Note: USP General Chapter <1121> Nomenclature refers to the USP Nomenclature
963 	Guidelines that currently restrict the use of “concentrate” to drug substances that are not
964 	intended for direct administration.
965
966 	Cream
967 	A cream is a semisolid emulsion dosage form. It is assumed to be topical unless otherwise
968 	specified.
969
970 	cream
971 	vaginal cream
972
973 	Drop — not preferred, see the appropriate dosage form (e.g., “Solution” or “Suspension”)
974
975 	Elixir — not preferred, see “Solution”
976
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977 	Emulsion
978 	Emulsion is used as a dosage form term only when a more specific term (e.g., cream, lotion,
979 	ointment) is not applicable.
980
981 	ophthalmic emulsion
982 	oral emulsion
983 	topical emulsion — not preferred, see “Lotion”
984 	see also “Injection” for injectable emulsion
985
986 	Film
987 	A film is a thin sheet of material.
988
989 	buccal film
990 	oral film
991 	sublingual film
992
993 	Foam
994
995 	topical foam
996 	see also “Injection” for injectable foam
997
998 	Gas
999 	The name of the specific gas should be used without the use of the term “gas.”
1000
1001 	medical air
1002 	oxygen
1003
1004 	Gel
1005
1006 	dental gel
1007 	nasal gel
1008 	ophthalmic gel
1009 	oral gel
1010 	periodontal gel
1011 	topical gel
1012 	vaginal gel
1013
1014 	Gels
1015
1016 	chewable gels
1017
1018 	Granule
1019 	This term should be used when the drug product is administered as granules. For granules
1020 	that are reconstituted to make the administered dosage form, the word “for” should be
1021 	inserted in front of the route of administration and dosage form. For example: In the case of
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1022 	granules that are reconstituted to make an oral solution, the appropriate nomenclature would
1023 	be “[DRUG] for oral solution.”
1024
1025 	oral granules
1026
1027 	Gum
1028
1029 	Gum
1030
1031 	Implant
1032 	Implants are inserted into the body often using a special injector or by surgical incision. As
1033 	with injections, the specific route of administration typically is not included in the
1034 	nonproprietary name unless there is only a single anatomical location for the implant.
1035
1036 	implant(s)
1037 	intravitreal implant
1038
1039 	Inhalant
1040 	The FDA and USP need to have further discussion regarding this dosage form.
1041
1042 	inhalant(s)
1043
1044 	Inhalation — not preferred, see the appropriate dosage form (e.g., “Solution” or “Suspension”)
1045 	Health care providers often use the term “inhalation” as a dosage form when it is actually a
1046 	method of administration. Inhaled drug products are administered orally with the use of a
1047 	nebulization system or an external nebulizer. “Sterile water for inhalation” is the only drug
1048 	product that uses “inhalation” as the dosage form.
1049
1050 	Injection
1051 	For injections, the route should not be included in the nonproprietary name. The specific
1052 	route of administration (e.g., intramuscular, subcutaneous) appears elsewhere.
1053
1054 	injection
1055 	for injection
1056 	extended-release injection
1057 	injectable emulsion
1058 	injectable foam
1059 	injectable suspension
1060 	for injectable suspension
1061 	extended-release injectable suspension (The USP Nomenclature, Safety and Labeling
1062 	Expert Committee voted to adopt this terminology, but the terminology has not yet
1063 	become official in the United States Pharmacopeia-National Formulary (USP-NF).)
1064 	for extended-release injectable suspension (The USP Nomenclature, Safety and Labeling
1065 	Expert Committee voted to adopt this terminology, but the terminology has not yet
1066 	become official in the USP-NF.)
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1067 	for injection concentrate (Currently reserved for “potassium chloride for injection
1068 	concentrate.” This terminology is restricted for use with only this drug product by the
1069 	USP Nomenclature Guidelines that are referenced in General Chapter <1121>.
1070 	Therefore, it may not be used for another drug product unless the FDA and USP agree
1071 	its use is appropriate.)
1072 	see also “Lipid Complex” and “Liposome”
1073
1074 	Drug products for infusion have monograph titles based on the following general format:
1075
1076 	[drug] in [vehicle] injection
1077
1078 	Specific examples of formats that currently appear in the USP are shown below. The
1079 	concentration of the vehicle(s) named in the official title is/are stated as if part of the official
1080 	title (e.g., “dextrose injection 5%,” or “dextrose (5%) and sodium chloride (0.2%) injection”)
1081 	on the container label and carton labeling, but not on the product title line.
1082
1083 	in dextrose injection
1084 	in dextrose and sodium chloride injection
1085 	in lactated ringer’s and dextrose injection
1086 	in sodium chloride injection
1087
1088 	Insert
1089 	Note: Inserts are inserted into a naturally occurring body cavity other than the mouth or
1090 	rectum. See “Suppository” for drug products inserted into the rectum.
1091
1092 	urethral inserts
1093 	vaginal inserts
1094
1095 	Irrigation
1096 	Irrigation is a sterile solution intended to bathe or flush open wounds or body cavities.
1097 	Irrigations are used to rinse body surfaces other than the mouth. There is a need to carefully
1098 	differentiate among related terms (e.g., irrigation, rinse, and solution). The route of
1099 	administration typically is not included in the nonproprietary name unless there is a highly
1100 	specific route.
1101
1102 	irrigation
1103 	for irrigation
1104 	intraocular irrigation
1105
1106 	Jelly — not preferred, see “Gel”
1107
1108 	Kit — not a dosage form
1109
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1110 	Lipid Complex
1111 	A lipid complex is not a dosage form. However, it has been included in this list to assist the
1112 	user in developing proper nomenclature for drug products that are lipid complexes. The
1113 	general nomenclature format is:
1114
1115 	[drug] lipid complex type X [dosage form]
1116
1117 	The drug name and dosage form replace the brackets. Applicants should assume that the first
1118 	lipid complex product approved for a particular drug and dosage form is type A, so the type
1119 	should not be given (i.e., “type A” should not be included in the labeling). For subsequent
1120 	drug products of the same drug and dosage form, applicants should list the type and replace
1121 	“X” sequentially with B, C, D, . . . Z.
1122
1123 	Liposome
1124 	A liposome is not a dosage form. However, it has been included in this list to assist the user
1125 	in developing proper nomenclature for liposomal drug products. The general nomenclature
1126 	format is:
1127
1128 	[drug] liposome type X [dosage form]
1129
1130 	Or
1131
1132 	[drug] pegylated liposome type X [dosage form]
1133
1134 	The drug name and dosage form replace the brackets. Applicants should assume that the first
1135 	liposome product approved for a particular drug and dosage form is type A, so the type
1136 	should not be given (i.e., “type A” should not be included in the labeling). For subsequent
1137 	drug products of the same drug and dosage form, applicants should list the type and replace
1138 	“X” sequentially with B, C, D, . . . Z.
1139
1140 	Liquid
1141 	A liquid is a dosage form consisting of a pure chemical in its liquid state. This dosage form
1142 	should not be applied to solutions. Typically, the term “liquid” is not used in drug product
1143 	nonproprietary names. Rare exceptions may be permitted (e.g., oral liquid).
1144
1145 	Lotion
1146 	A lotion is an emulsion, liquid dosage form. It is assumed to be topical.
1147
1148 	lotion
1149
1150 	Lozenge
1151 	A lozenge is assumed to be oral.
1152
1153 	lozenges
1154
1155 	Mouthwash — not preferred, see “Rinse”
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1156
1157 	Ointment
1158 	An ointment is assumed to be topical unless otherwise specified. If multiple routes are
1159 	approved (e.g., topical and rectal), no route is associated with the dosage form term (e.g.,
1160 	ointment). The route should be included only if it is the sole approved nontopical route (e.g.,
1161 	ophthalmic ointment).
1162
1163 	ointment
1164 	nasal ointment
1165 	ophthalmic ointment
1166
1167 	Paste
1168 	A paste is assumed to be topical unless otherwise specified.
1169
1170 	paste
1171 	dental paste
1172 	oral paste
1173
1174 	Patch — not preferred for use in nonbiologic drug product nomenclature, see “System”
1175 	Note: This term has been used historically for allergen patch test products.
1176
1177 	Pellet
1178 	See also “Implant”; many pelletized dosage forms are implants. The FDA and USP need to
1179 	have further discussion concerning this dosage form.
1180
1181 	pellets
1182 	oral pellets
1183
1184 	Pill — not preferred, see “Tablet” or “Capsule”
1185 	Note: Pill is reserved for a solid, spherical dosage form usually prepared by a wet massing,
1186 	piping, and molding technique.
1187
1188 	Plaster — not preferred
1189
1190 	Pledget — not preferred, see “Swab”
1191
1192 	Powder
1193 	This term is used when the drug product is administered as a powder. For a powder that is
1194 	reconstituted to make the administered dosage form, the word “for” should be inserted in
1195 	front of the route of administration and dosage form. For example: In the case of a powder
1196 	that is reconstituted to make an oral solution, the appropriate terminology would be
1197 	“[DRUG] for oral solution.”
1198
1199 	inhalation powder — assumed to be for oral inhalation
1200 	nasal powder — used topically in the nose
1201 	nasal inhalation powder — used for powder inhaled through the nose
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1202 	oral powder
1203 	topical powder
1204
1205 	Rinse
1206 	This term is reserved for drug products that are used to rinse the mouth, then expectorated.
1207 	Use “Irrigation” for other routes of administration when the solution is used for rinsing.
1208
1209 	rinse
1210
1211 	Shampoo
1212 	A shampoo is assumed to be topical.
1213
1214 	shampoo
1215
1216 	Soap
1217 	A soap is assumed to be topical.
1218
1219 	soap
1220
1221 	Solution
1222
1223 	inhalation solution
1224 	for inhalation solution — a powder that is reconstituted to make an inhalation solution
1225 	intraocular solution
1226 	intravesical solution
1227 	nasal solution — for local application to the nasal passages. A nasal solution will be
1228 	assumed not to be metered unless labeling indicates that it is metered.
1229 	ophthalmic solution
1230 	for ophthalmic solution
1231 	oral solution
1232 	for oral solution
1233 	for effervescent oral solution
1234 	otic solution
1235 	for otic solution
1236 	rectal solution
1237 	solution — may appear without a route in unique circumstances such as when the
1238 	solution is either: (1) for ex-vivo use (e.g., to radiolabel blood cells that subsequently
1239 	will be readministered to a patient); or (2) labeled for both oral and rectal
1240 	administration, where it would be misleading as either oral solution or rectal
1241 	solution.40
1242 	solution for inhalation — a solution that has to be diluted before it is administered
1243 	topical solution
1244 	for topical solution
40 The FDA text differs from the USP text because the USP text also addresses the development of titles for
disinfectants that are not regulated as drug products.
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1245 	see also “Injection,” “Inhalation,” “Irrigation,” “Rinse,” “Shampoo,” “Soap,” and
1246 	“Spray”
1247
1248 	Spirit — not preferred, see “Solution”
1249
1250 	Spray
1251 	Sprays are nonpressurized dosage forms. All sprays are assumed to be metered except the
1252 	topical sprays. Topical sprays are assumed not to be metered unless labeling indicates they
1253 	are metered.
1254
1255 	inhalation spray — assumed to be for oral inhalation
1256 	lingual spray
1257 	nasal spray
1258 	oral spray
1259 	topical spray
1260
1261 	Strip — used only for diagnostic drug products, otherwise not preferred, see “Film”
1262
1263 	Suppository
1264 	This term is reserved for drug products inserted into the rectum. See “Insert” for drug
1265 	products inserted into other body cavities.
1266
1267 	suppositories
1268
1269 	Suspension
1270
1271 	inhalation suspension
1272 	ophthalmic suspension
1273 	for ophthalmic suspension
1274 	oral suspension
1275 	delayed-release oral suspension
1276 	extended-release oral suspension
1277 	for oral suspension
1278 	for delayed-release oral suspension
1279 	for extended-release oral suspension
1280 	otic suspension
1281 	for otic suspension
1282 	rectal suspension
1283 	suspension — may appear without a route in unique circumstances such as when the
1284 	suspension is either: (1) for ex-vivo use (e.g., to radiolabel blood cells that
1285 	subsequently will be readministered to a patient); or (2) labeled for both oral and
1286 	rectal administration, where it would be misleading as either oral suspension or rectal
1287 	suspension.41
1288 	suspension for inhalation — a suspension that has to be diluted before it is administered
41 The FDA text differs from the USP text because the USP text also addresses the development of titles for
disinfectants that are not regulated as drug products.
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1289 	topical suspension
1290 	for topical suspension
1291 	see also “Injection,” “Inhalation,” “Irrigation,” “Rinse,” “Shampoo,” “Soap,” and
1292 	“Spray”
1293
1294 	Swab
1295 	A swab is assumed to be topical unless otherwise specified. The FDA and USP need to have
1296 	further discussion regarding this dosage form.
1297
1298 	swabs
1299
1300 	Syrup — not preferred, see “Solution” or “Suspension”
1301
1302 	System
1303 	This term is used for a drug-containing delivery system that controls the release rate of the
1304 	drug product from the system by diffusion kinetics, active transport, or other means. The
1305 	activity is defined in terms of the release rate of the active ingredient(s) from the system over
1306 	a stated period of time. The rate of release and the total duration of drug release typically
1307 	appear on the drug product and on the container label and carton labeling, but not on the
1308 	product title line.
1309
1310 	intrauterine systems
1311 	ocular systems
1312 	oral mucosal systems
1313 	periodontal systems
1314 	topical systems
1315 	transdermal systems
1316 	iontophoretic transdermal systems
1317 	vaginal systems
1318
1319 	Tablet
1320 	Note: In the past, the terminology “vaginal tablets” was used, but these drug products are
1321 	now referred to as “vaginal inserts.”
1322
1323 	tablets
1324 	buccal tablets
1325 	chewable tablets — only if the tablet MUST ALWAYS be chewed; if it MAY be
1326 	chewed, use “tablets”
1327 	delayed-release tablets
1328 	extended-release tablets
1329 	orally disintegrating tablets
1330 	delayed-release orally disintegrating tablets
1331 	sublingual tablets
1332 	tablets for oral solution
1333 	effervescent tablets for oral solution — A special type of tablet that is intended to be
1334 	dissolved in water before administration. It contains mixtures of acids (e.g., citric
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1335 	acid, tartaric acid) and carbonates and/or hydrogen carbonates, and upon contact with
1336 	water it releases carbon dioxide.
1337 	tablets for topical solution
1338 	tablets for oral suspension
1339
1340 	Tape — not preferred
1341
1342 	Tincture — not preferred, see “Solution”
1343
1344 	Troche — not preferred, see “Lozenge”
1345
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1346 	APPENDIX B:
1347 	ROUTE OF ADMINISTRATION TERMS FOR USE IN THE PRODUCT TITLE
1348
1349 	The following table lists the most commonly used route of administration terms for use in the
1350 	product title. This list is derived from the FDA Data Standards Manual Route of Administration
1351 	list with minor differences made to create a list that is appropriate for use in the product title. If
1352 	an applicant determines that a route of administration term different from any of the examples is
1353 	appropriate, the applicant is encouraged to initiate discussions with the FDA.
1354
Name 	Definition
Buccal 	Administration directed toward the cheek, generally
from within the mouth
Dental 	Administration to a tooth or teeth
Endocervical 	Administration within the canal of the cervix uteri
Endotracheal 	Administration directly into the trachea
Enteral 	Administration directly into the intestines
Epidural 	Administration on or over the dura mater
Extracorporeal
(For certain radiopharmaceuticals, it
may be appropriate to use the phrase
“for radiolabeling” instead of the
route of administration
“extracorporeal.”
Administration outside of the body
Hemodialysis 	Administration through hemodialysate fluid
Infiltration 	Administration that results in substances passing
into tissue spaces or into cells
Inhalation 	Administration within the respiratory tract by
inhaling orally and nasally for local or systemic
effect
(For purposes of the product title, this term is
reserved for drug products that can be administered
both orally and nasally (see also ORAL
INHALATION and NASAL INHALATION).)
Interstitial 	Administration to or in the interstices of a tissue
Intra-abdominal 	Administration within the abdomen
1355 	continued
36

Contains Nonbinding Recommendations
Draft — Not for Implementation
1356 	continued
Name 	Definition
Intra-amniotic 	Administration within the amnion
Intra-arterial 	Administration within an artery or arteries
Intra-articular 	Administration within a joint
Intrabiliary 	Administration within the bile, bile ducts, or
gallbladder
Intrabronchial 	Administration within a bronchus
Intrabursal 	Administration within a bursa
Intracardiac 	Administration within the heart
Intracaudal 	Administration within the cauda equina
Intracavernous 	Administration within a pathologic cavity, such as
occurs in the lung in tuberculosis
Intracorneal 	Administration within the cornea (the transparent
structure forming the anterior part of the fibrous
tunic of the eye)
Intradermal 	Administration within the dermis
Intradiscal 	Administration within a disc
Intraductal 	Administration within the duct of a gland
Intragingival 	Administration within the gingivae
Intralesional 	Administration within or introduced directly into a
localized lesion
Intramuscular 	Administration within a muscle
Intraocular 	Administration within the eye
Intrapericardial 	Administration within the pericardium
Intraperitoneal 	Administration within the peritoneal cavity
Intrapleural 	Administration within the pleura
Intrasynovial 	Administration within the synovial cavity of a joint
Intratesticular 	Administration within the testicle
1357 	continued
37

Contains Nonbinding Recommendations
Draft — Not for Implementation
1358 	continued
Name 	Definition
Intratympanic 	Administration within the auris media
Intrauterine 	Administration within the uterus
Intravenous 	Administration within or into a vein or veins
Intravesical 	Administration within the bladder
Intravitreal 	Administration within the vitreous body of the eye
Nasal 	Administration to the nose; administered by way of
the nose
Nasal inhalation 	Administration by way of the nose for local or
systemic effect (see INHALATION)
Ophthalmic 	Administration to the external eye
Oral 	Administration to or by way of the mouth
Oral inhalation 	Administration by way of the mouth and intended
for delivery to the respiratory tract for local or
systemic effect (see INHALATION)
Oropharyngeal 	Administration directly to the mouth and pharynx
Otic 	Administration to or by way of the ear
Periodontal 	Administration around a tooth
Rectal 	Administration to the rectum
Retrobulbar 	Administration behind the pons or behind the
eyeball
Soft tissue 	Administration into any soft tissue
Subarachnoid 	Administration beneath the arachnoid
Subconjunctival 	Administration beneath the conjunctiva
Subcutaneous 	Administration beneath the skin; hypodermic
Sublingual 	Administration beneath the tongue
Topical 	Administration on the outer surface of the body
(For purposes of the product title, this term applies
to products with either local or systemic effect.)
1359 	continued
38

1361
Contains Nonbinding Recommendations
Draft — Not for Implementation
1360 	continued
Name 	Definition
Transdermal 	Administration through the dermal layer of the skin
to the systemic circulation by diffusion
(For purposes of the product title, this term applies
to delivery systems that are applied to the skin.)
Transmucosal 	Administration across the mucosa
Transtracheal 	Administration through the wall of the trachea
Urethral 	Administration into the urethra
Vaginal 	Administration into the vagina
39