azithromycin

Product NDC: 71610-381
Requested package NDC: 71610-381-06
11-digit product format: 716100381
Labeler code: 71610
Product ID: 71610-381_2b930ea4-fa18-4ef0-be78-7f8f715acc15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA050711
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-05-13
Marketing end: 0000-00-00
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 250 mg/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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71610-381	71610-381-06	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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
N050711-001	ZITHROMAX	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050711-001	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 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050711-001	ZITHROMAX	EQ 250MG BASE	TABLET / ORAL	AB	RLD	1996-07-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N050711-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050711-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050711-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050711-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050711-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050711-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050711-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050711-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050711-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050711-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050711-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050711-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050711-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050711-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050711-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050711-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050711-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050711-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050711-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050711-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050711-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050711-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050711-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050711-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050711-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050711-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050711-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050711-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050711-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050711-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050711-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050711-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050711-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050711-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050711-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050711-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050711-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050711-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050711-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050711-001	AB	1	`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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71610-381-06	2023-01-30	C162847	48780-1	f386c649-c881-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 250 mg and 500 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
71610-381-06	azithromycin	6 in 1 BOTTLE	TABLET, FILM COATED	6		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-381-06	EA - Each	71610-381	f63dfb66-5f7c-4b02-add2-2733fdbca9c8	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-381	AZITHROMYCIN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 1 package rows	20200125_2414dc57-e373-485a-bc8e-b86c2aeb1d38.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zithromax	AZITHROMYCIN DIHYDRATE	Pfizer Laboratories Div Pfizer Inc	db52b91e-79f7-4cc1-9564-f2eee8e31c45	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050711 application number: NDA050711
Zithromax	AZITHROMYCIN DIHYDRATE	Redpharm Drug	3ddecd25-dc32-a2af-e063-6294a90a526d	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050711 application number: NDA050711

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
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	2414dc57-e373-485a-bc8e-b86c2aeb1d38	1
308460	azithromycin 250 MG Oral Tablet	PSN	2414dc57-e373-485a-bc8e-b86c2aeb1d38	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	2414dc57-e373-485a-bc8e-b86c2aeb1d38	1
308460	azithromycin 250 MG Oral Tablet	SCD	2414dc57-e373-485a-bc8e-b86c2aeb1d38	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	2414dc57-e373-485a-bc8e-b86c2aeb1d38	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71610-381-06	71610038106	6 TABLET, FILM COATED in 1 BOTTLE (71610-381-06)	2020-01-02	0000-00-00	No	No	Current