Azithromycin

Product NDC: 43386-470
11-digit product format: 433860470
Labeler code: 43386
Product ID: 43386-470_ab3a02b3-6189-4b1f-a9eb-d02b9e313fb3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: FOR SUSPENSION
Route: ORAL
Labeler: Lupin Pharmaceuticals,Inc.
Application: ANDA065488
Marketing category: ANDA
Marketing start: 2017-09-27
Marketing end: 0000-00-00
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 100 mg/5mL
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43386-470		I	Inactivated by FDA		2026-08-03
excluded package	package	43386-470	43386-470-60	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 32 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43386-470-60	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43386-470-60	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43386-470-60	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43386-470-60	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43386-470-60	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43386-470-60	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43386-470-60	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43386-470-60	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43386-470-60	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43386-470-60	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43386-470-60	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43386-470-60	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43386-470-60	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43386-470-60	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43386-470-60	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	43386-470-60	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065488-001	AZITHROMYCIN	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2015-05-15
A065488-002	AZITHROMYCIN	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB		2015-05-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065488-001	AB
A065488-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2015-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2015-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2015-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2015-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2015-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2015-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2015-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2015-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2015-05-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL	AB	2015-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065488-001	AZITHROMYCIN	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065488-002	AZITHROMYCIN	EQ 200MG BASE/5ML	FOR SUSPENSION / ORAL		2015-05-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065488-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065488-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065488-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065488-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065488-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065488-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065488-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065488-002	AB	1	`fd3edfee7708…`
2019-12-13 00:20 UTC	2019-12	A065488-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065488-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A065488-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065488-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065488-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065488-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065488-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065488-002	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065488-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A065488-002	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401	Product name	9	20200616
a2cbe82e-b432-4f71-954b-75e9214e8567	Product name	3	20200612
371533fa-efb3-4c48-b5e4-60179db407f3	Product name	3	20190124

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43386-470-60	2024-01-30	C162847	48780-1	1030e365-6c4f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43386-470-60	Azithromycin	1 in 1 CARTON	FOR SUSPENSION	1		3
43386-470-60	Azithromycin	15 mL in 1 BOTTLE	FOR SUSPENSION	15		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43386-470-60	ML - Milliliter	43386-470	d0eb0216-d720-499b-a8f9-c66eb61dd1a0	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43386-470	AZITHROMYCIN FOR SUSPENSION [LUPIN PHARMACEUTICALS,INC.]	3	Legacy NDC, 2 package rows	20191221_0ab1486a-b890-45a1-9bfc-cf72d7cb9dd1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Chartwell RX, LLC	2c9de2e9-c20c-4660-a272-a22019f9fb02	2024-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065488 application number: ANDA065488

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JTE4MNN1MD	AZITHROMYCIN MONOHYDRATE	121470-24-4	AZITHROMYCIN MONOHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308459	azithromycin 100 MG in 5 mL Oral Suspension	PSN	0ab1486a-b890-45a1-9bfc-cf72d7cb9dd1	3
141963	azithromycin 200 MG in 5 mL Oral Suspension	PSN	0ab1486a-b890-45a1-9bfc-cf72d7cb9dd1	3
308459	azithromycin 20 MG/ML Oral Suspension	SCD	0ab1486a-b890-45a1-9bfc-cf72d7cb9dd1	3
141963	azithromycin 40 MG/ML Oral Suspension	SCD	0ab1486a-b890-45a1-9bfc-cf72d7cb9dd1	3
308459	azithromycin 100 MG per 5 ML Oral Suspension	SY	0ab1486a-b890-45a1-9bfc-cf72d7cb9dd1	3
141963	azithromycin 1200 MG per 30 ML Oral Suspension	SY	0ab1486a-b890-45a1-9bfc-cf72d7cb9dd1	3
141963	azithromycin 200 MG per 5 ML Oral Suspension	SY	0ab1486a-b890-45a1-9bfc-cf72d7cb9dd1	3
141963	azithromycin 600 MG per 15 ML Oral Suspension	SY	0ab1486a-b890-45a1-9bfc-cf72d7cb9dd1	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43386-470-60	43386047060	1 BOTTLE in 1 CARTON (43386-470-60) > 15 mL in 1 BOTTLE	1 bottle	2017-09-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin	Lupin Pharmaceuticals,Inc. \| Novel Laboratories, Inc.	2019-12-12	HUMAN PRESCRIPTION DRUG LABEL	3