azithromycin

Product NDC: 53002-2225
11-digit product format: 530022225
Labeler code: 53002
Product ID: 53002-2225_03c71cee-5bd5-4245-8ee9-eb9166db6663
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AZITHROMYCIN
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: NDA050693
Marketing category: NDA
Marketing start: 1999-02-12
Marketing end: 0000-00-00
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 1 g/1
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	53002-2225		I	Inactivated by FDA		2026-08-17
excluded package	package	53002-2225	53002-2225-1	I	Inactivated by FDA		2026-08-17

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 · 22 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	53002-2225-1	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	53002-2225-1	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	53002-2225-1	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	53002-2225-1	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	53002-2225-1	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	53002-2225-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53002-2225-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53002-2225-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53002-2225-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53002-2225-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53002-2225-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N050693-001	ZITHROMAX	AZITHROMYCIN	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL		RLD	1994-09-28

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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD	1994-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD	1994-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD	1994-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD	1994-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050693-001	ZITHROMAX	EQ 1GM BASE/PACKET	FOR SUSPENSION / ORAL	RLD, RS	1994-09-28	`e64feba35796…`

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#

Effective, Related label table
Effective	Related label
2025-01-30	These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
2023-06-07	These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
2023-01-30	These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
2020-12-15	These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
2020-01-31	These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use 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
53002-2225-1	azithromycin	1 in 1 PACKET	POWDER, FOR SUSPENSION	1		5
53002-2225-1	azithromycin	3 in 1 BOX	POWDER, FOR SUSPENSION	3		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-2225	AZITHROMYCIN POWDER, FOR SUSPENSION [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 2 package rows	20230609_0188acfd-cc89-4486-8bcf-93a53340dfca.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5FD1131I7S	AZITHROMYCIN DIHYDRATE	117772-70-0	AZITHROMYCIN DIHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861416	azithromycin 1 GM Powder for Oral Suspension	PSN	0188acfd-cc89-4486-8bcf-93a53340dfca	5
861416	azithromycin 1000 MG Powder for Oral Suspension	SCD	0188acfd-cc89-4486-8bcf-93a53340dfca	5
861416	azithromycin 1 GM Powder for Oral Suspension	SY	0188acfd-cc89-4486-8bcf-93a53340dfca	5
861416	azithromycin 1000 MG Powder for Oral Suspension	SY	0188acfd-cc89-4486-8bcf-93a53340dfca	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-2225-1	53002222501	3 PACKET in 1 BOX (53002-2225-1) > 1 POWDER, FOR SUSPENSION in 1 PACKET	3 packet	2018-10-01	0000-00-00	No	No	Current