azithromycin monohydrate

Product NDC: 57297-162
11-digit product format: 572970162
Labeler code: 57297
Product ID: 57297-162_0d4e2766-a243-44a9-801e-b4e4abcc59a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin monohydrate
Dosage form: TABLET
Route: ORAL
Labeler: LUPIN LIMITED
Application: ANDA065400
Marketing category: ANDA
Marketing start: 2015-07-22
Marketing end: 0000-00-00
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 600 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	57297-162		D	Discontinued by firm		2026-08-03
excluded package	package	57297-162	57297-162-06	D	Discontinued by firm		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	57297-162		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57297-162	57297-162-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	57297-162		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57297-162	57297-162-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	57297-162		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57297-162	57297-162-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	57297-162		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57297-162	57297-162-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	57297-162		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57297-162	57297-162-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	57297-162		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57297-162	57297-162-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	57297-162		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57297-162	57297-162-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	57297-162		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57297-162	57297-162-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	57297-162		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57297-162	57297-162-06	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product	57297-162		I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	57297-162	57297-162-06	I	Inactivated by FDA	excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	57297-162		E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	57297-162	57297-162-06	E	Excluded after deficient or non-compliant submission was not corrected	excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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

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
A065400-001	AZITHROMYCIN	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB		2015-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065400-001	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 · 41 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	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065400-001	AZITHROMYCIN	EQ 600MG BASE	TABLET / ORAL	AB	2015-05-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065400-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065400-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065400-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065400-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065400-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065400-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065400-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065400-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065400-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065400-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065400-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065400-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065400-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065400-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065400-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065400-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065400-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065400-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065400-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065400-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065400-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065400-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065400-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065400-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065400-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065400-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065400-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065400-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065400-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065400-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065400-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065400-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065400-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065400-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065400-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065400-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065400-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065400-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065400-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065400-001	AB	1	`cb3db0bc1861…`

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
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	c9990a1d-5238-403e-9221-72a9314d7b5e	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065400 application number: ANDA065400
azithromycin dihydrate	AZITHROMYCIN DIHYDRATE	Coupler LLC	2cc93e72-95ce-965b-e063-6394a90a8917	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065400 application number: ANDA065400

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57297-162-06	2024-12-20	C162847	48780-1	9d75b9d0-fb50-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use azithromycin tablets USP safely and effectively. See full prescribing information for azithromycin tablets USP. AZITHROMYCIN tablets USP, 600 mg, for oral use Initial U.S. Approval: 1991
57297-162-06	2020-01-31	C162847	48780-1	9d75b9d0-fb50-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use azithromycin tablets USP safely and effectively. See full prescribing information for azithromycin tablets USP. AZITHROMYCIN tablets USP, 600 mg, for oral use Initial U.S. Approval: 1991