Azithromycin

Product NDC: 16571-696
11-digit product format: 165710696
Labeler code: 16571
Product ID: 16571-696_e8114fdc-e28b-406b-bbcb-6a441de60b95
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA207398
Marketing category: ANDA
Marketing start: 2018-07-05
Marketing end: 0000-00-00
Substance: AZITHROMYCIN DIHYDRATE
Active strength: 500 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16571-696		D	Discontinued by firm	2026-08-10
excluded package	package	16571-696	16571-696-03	D	Discontinued by firm	2026-08-10
excluded package	package	16571-696	16571-696-13	D	Discontinued by firm	2026-08-10
excluded package	package	16571-696	16571-696-91	D	Discontinued by firm	2026-08-10

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16571-696-91	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16571-696-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16571-696-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16571-696-91	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16571-696-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16571-696-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16571-696-91	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16571-696-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16571-696-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16571-696-91	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16571-696-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16571-696-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16571-696-91	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16571-696-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16571-696-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16571-696-91	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16571-696-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16571-696-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16571-696-91	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16571-696-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16571-696-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16571-696-91	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16571-696-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16571-696-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16571-696-91	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16571-696-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16571-696-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16571-696-91	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16571-696-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16571-696-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16571-696-91	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16571-696-13	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16571-696-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16571-696-91	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16571-696-13	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16571-696-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A207398-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB		2018-07-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207398-001	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	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207398-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2018-07-05	`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	A207398-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207398-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207398-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207398-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207398-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207398-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207398-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207398-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207398-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207398-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207398-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207398-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207398-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207398-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207398-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207398-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207398-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207398-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207398-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207398-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207398-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207398-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207398-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207398-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207398-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207398-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207398-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207398-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207398-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207398-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207398-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207398-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207398-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207398-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207398-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207398-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207398-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207398-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207398-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207398-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-696-03	EA - Each	16571-696	7a0e7678-245c-4d61-9b56-00ba444a18f2	1	2020-06-05

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	882f71b1-b153-4856-b4a7-1a29ae9cf247	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	58308e8b-57bd-4e82-a2e8-24aac63194cd	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	2a8010dc-700f-45d3-94ca-ebe4a51acc1b	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Aurobindo Pharma Limited	795c13cd-e9ca-481b-9fa9-2890bdf9dac8	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	a81212ef-76b6-4bd7-8706-3d2b05ee34f9	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	24c07398-84ad-48e2-9625-e9073c28fb73	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	77c5e4c6-6d16-40fe-bf36-cb441348f39b	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	003307c5-3f73-4a5d-a704-bfdea3c656e8	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Redpharm Drug	2fd25741-f014-3999-e063-6394a90acdd0	2025-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	94e17ae5-0871-67a0-e053-2995a90ae0ae	2025-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
AZITHROMYCIN	AZITHROMYCIN	Direct_Rx	8e6e11fb-eb9e-28ec-e053-2a95a90aa1a3	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	9270e676-3382-6483-e053-2a95a90a556e	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	8e7184e1-3c3c-cd87-e053-2a95a90a6eb6	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398
Azithromycin	AZITHROMYCIN	Proficient Rx LP	25f2d819-ae38-4061-a897-bbcfce3739bf	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207398 application number: ANDA207398

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-696-03	16571069603	30 TABLET, FILM COATED in 1 BOTTLE (16571-696-03)		2018-07-05	0000-00-00	No	No	Current
16571-696-13	16571069613	1 BLISTER PACK in 1 CARTON (16571-696-13) > 3 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2018-07-05	0000-00-00	No	No	Current
16571-696-91	16571069691	3 BLISTER PACK in 1 CARTON (16571-696-91) > 3 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2018-07-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2021-12-21	Human Prescription Drug Label	4