Azithromycin

Product NDC: 62980-961
11-digit product format: 629800961
Labeler code: 62980
Product ID: 62980-961_abb76e1d-a0c6-407b-b70c-1d5da87f4902
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Vivimed Labs Limited
Application: ANDA065404
Marketing category: ANDA
Marketing start: 2008-02-11
Marketing end: 0000-00-00
Substance: AZITHROMYCIN ANHYDROUS
Active strength: 250 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	62980-961		I	Inactivated by FDA	2026-08-03
excluded package	package	62980-961	62980-961-01	I	Inactivated by FDA	2026-08-03
excluded package	package	62980-961	62980-961-02	I	Inactivated by FDA	2026-08-03
excluded package	package	62980-961	62980-961-05	I	Inactivated by FDA	2026-08-03
excluded package	package	62980-961	62980-961-07	I	Inactivated by FDA	2026-08-03
excluded package	package	62980-961	62980-961-08	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 3 · 132 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	62980-961-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62980-961-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62980-961-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62980-961-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62980-961-05	`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	62980-961-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62980-961-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62980-961-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62980-961-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62980-961-05	`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	62980-961-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62980-961-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62980-961-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62980-961-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62980-961-05	`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	62980-961-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62980-961-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62980-961-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62980-961-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62980-961-05	`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	62980-961-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62980-961-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62980-961-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62980-961-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62980-961-05	`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	62980-961-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62980-961-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62980-961-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62980-961-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62980-961-05	`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	62980-961-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62980-961-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62980-961-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62980-961-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62980-961-05	`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	62980-961-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62980-961-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62980-961-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62980-961-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62980-961-05	`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	62980-961-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62980-961-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62980-961-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62980-961-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62980-961-05	`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	62980-961-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62980-961-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62980-961-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62980-961-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62980-961-05	`ad56d346431e…`	`cc804d4bbf1e…`

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
A065404-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB		2008-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065404-001	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	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065404-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2008-02-11	`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	A065404-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065404-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065404-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065404-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065404-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065404-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065404-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065404-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065404-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065404-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065404-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065404-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065404-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065404-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065404-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065404-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065404-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065404-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065404-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065404-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065404-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065404-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065404-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065404-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065404-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065404-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065404-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065404-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065404-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065404-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065404-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065404-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065404-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065404-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065404-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065404-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065404-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065404-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065404-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065404-001	AB	1	`cb3db0bc1861…`

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, Related label table
NDC	Related label
62980-961-01	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
62980-961-02	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
62980-961-05	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
62980-961-07	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991
62980-961-08	These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN Tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62980-961-01	Azithromycin	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
62980-961-02	Azithromycin	10 in 1 CARTON	TABLET, FILM COATED	10	2
62980-961-04	Azithromycin	6 in 1 BLISTER PACK	TABLET, FILM COATED	6	2
62980-961-05	Azithromycin	3 in 1 CARTON	TABLET, FILM COATED	3	2
62980-961-07	Azithromycin	500 in 1 BOTTLE	TABLET, FILM COATED	500	2
62980-961-08	Azithromycin	3500 in 1 BAG	TABLET, FILM COATED	3500	2
62980-961-09	Azithromycin	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
MAGNESIUM TRISILICATE	INACTIVE INGREDIENT	C2E1CI501T	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62980-961	AZITHROMYCIN TABLET, FILM COATED [VIVIMED LABS LIMITED]	2	Legacy NDC, 7 package rows	20170926_f6edd3c1-4455-4f05-b554-49d59d442270.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J2KLZ20U1M	AZITHROMYCIN ANHYDROUS	83905-01-5	AZITHROMYCIN ANHYDROUS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
749780	{3 (azithromycin 500 MG Oral Tablet) } Pack	GPCK	f6edd3c1-4455-4f05-b554-49d59d442270	2
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	f6edd3c1-4455-4f05-b554-49d59d442270	2
308460	azithromycin 250 MG Oral Tablet	PSN	f6edd3c1-4455-4f05-b554-49d59d442270	2
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	f6edd3c1-4455-4f05-b554-49d59d442270	2
248656	azithromycin 500 MG Oral Tablet	PSN	f6edd3c1-4455-4f05-b554-49d59d442270	2
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	PSN	f6edd3c1-4455-4f05-b554-49d59d442270	2
308460	azithromycin 250 MG Oral Tablet	SCD	f6edd3c1-4455-4f05-b554-49d59d442270	2
248656	azithromycin 500 MG Oral Tablet	SCD	f6edd3c1-4455-4f05-b554-49d59d442270	2
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	f6edd3c1-4455-4f05-b554-49d59d442270	2
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	f6edd3c1-4455-4f05-b554-49d59d442270	2
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	SY	f6edd3c1-4455-4f05-b554-49d59d442270	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
62980-961-01	62980096101	30 in 1 BOTTLE	Historical
62980-961-02	62980096102	10 in 1 CARTON	Historical
62980-961-04	62980096104	6 in 1 BLISTER PACK	Historical
62980-961-05	62980096105	3 in 1 CARTON	Historical
62980-961-07	62980096107	500 in 1 BOTTLE	Historical
62980-961-08	62980096108	3500 in 1 BAG	Historical
62980-961-09	62980096109	10 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin	Vivimed Labs Limited \| Wockhardt Limited \| Vivimed Life Sciences Private Limited	2017-09-23	HUMAN PRESCRIPTION DRUG LABEL	2