Azithromycin

Product NDC: 64679-961
11-digit product format: 646790961
Labeler code: 64679
Product ID: 64679-961_d2a1950b-4358-ad27-e053-2a95a90a7f92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Wockhardt USA LLC.
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: No
Listing certified through: 2022-12-31
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	64679-961		D	Discontinued by firm	2026-08-03
excluded package	package	64679-961	64679-961-01	D	Discontinued by firm	2026-08-03
excluded package	package	64679-961	64679-961-02	D	Discontinued by firm	2026-08-03
excluded package	package	64679-961	64679-961-05	D	Discontinued by firm	2026-08-03
excluded package	package	64679-961	64679-961-07	D	Discontinued by firm	2026-08-03
excluded package	package	64679-961	64679-961-08	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 2 · 90 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-961-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-961-07	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-961-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-961-08	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64679-961-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-961-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-961-07	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-961-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-961-08	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64679-961-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-961-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-961-07	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-961-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-961-08	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64679-961-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-961-02	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-961-07	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-961-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-961-08	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64679-961-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-961-02	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-961-07	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-961-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-961-08	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64679-961-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-961-02	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-961-07	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-961-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-961-08	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64679-961-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-961-02	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-961-07	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-961-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-961-08	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64679-961-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-961-02	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-961-07	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-961-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-961-08	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64679-961-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-961-02	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-961-07	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-961-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-961-08	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64679-961-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-961-07	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-961-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-961-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-961-05	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64679-961-02	I	Inactivated by FDA	`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, Effective, Related label table
NDC	Effective	Related label
64679-961-01	2024-11-14	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
64679-961-02	2024-11-14	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
64679-961-05	2024-11-14	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
64679-961-07	2024-11-14	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
64679-961-08	2024-11-14	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
64679-961-01	2023-01-30	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
64679-961-02	2023-01-30	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
64679-961-05	2023-01-30	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
64679-961-07	2023-01-30	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
64679-961-08	2023-01-30	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64679-961-01	EA - Each	64679-961	644a2175-b839-428f-8572-d3c75e30d235	1	2012-07-24
64679-961-02	EA - Each	64679-961	d5e1d78d-7318-4405-9102-e13380aa2a3c	1	2022-04-06
64679-961-04	EA - Each	64679-961	b71506f1-f812-4bc6-b634-85425fc2028d	1	2012-07-24
64679-961-05	EA - Each	64679-961	d87c8206-1f44-470e-92a8-685622ffd913	1	2012-07-24
64679-961-07	EA - Each	64679-961	f0dc0378-b555-46df-bfab-188c80a5e7d2	1	2012-07-24
64679-961-08	EA - Each	64679-961	e93d0680-275d-4470-aa16-f2f7070b30c2	1	2022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Azithromycin Anhydrous	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Azithromycin Anhydrous	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Hydroxypropyl Cellulose (type H)	INACTIVE INGREDIENT	RFW2ET671P	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Magnesium Trisilicate	INACTIVE INGREDIENT	C2E1CI501T	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [AVPAK]	15
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
MAGNESIUM TRISILICATE	INACTIVE INGREDIENT	C2E1CI501T	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AZITHROMYCIN TABLET, FILM COATED [WOCKHARDT USA LLC.]	4
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]	2
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [RXCHANGE CO.]	2
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [UNIT DOSE SERVICES]	2
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [RXCHANGE CO.]	2
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
AZITHROMYCIN ANHYDROUS	ACTIVE INGREDIENT	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
AZITHROMYCIN	ACTIVE MOIETY	F94OW58Y8V	AZITHROMYCIN TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]	1
AZITHROMYCIN	ACTIVE MOIETY	F94OW58Y8V	AZITHROMYCIN (AZITHROMYCIN) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]	1
AZITHROMYCIN ANHYDROUS	ACTIVE MOIETY	J2KLZ20U1M	AZITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1

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
308460	azithromycin 250 MG Oral Tablet	PSN	7e6e1d06-5a28-4064-9bad-1c0303f5d555	8
308460	azithromycin 250 MG Oral Tablet	SCD	7e6e1d06-5a28-4064-9bad-1c0303f5d555	8
308460	azithromycin 250 MG Oral Tablet	PSN	85ff97e4-f161-4570-aa75-4b0dc4076e8f	6
308460	azithromycin 250 MG Oral Tablet	SCD	85ff97e4-f161-4570-aa75-4b0dc4076e8f	6
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	6c4ce016-e728-4d9a-b1c9-ffd2a8d15607	2
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	6307a49b-753a-4232-a51d-bf6d0537b05b	2
308460	azithromycin 250 MG Oral Tablet	PSN	330a082d-57b2-2bf5-e054-00144ff88e88	2
308460	azithromycin 250 MG Oral Tablet	PSN	6c4ce016-e728-4d9a-b1c9-ffd2a8d15607	2
308460	azithromycin 250 MG Oral Tablet	PSN	6307a49b-753a-4232-a51d-bf6d0537b05b	2
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	6307a49b-753a-4232-a51d-bf6d0537b05b	2
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	6c4ce016-e728-4d9a-b1c9-ffd2a8d15607	2
212446	Zithromax 250 MG Oral Tablet	PSN	330a082d-57b2-2bf5-e054-00144ff88e88	2
212446	azithromycin 250 MG Oral Tablet [Zithromax]	SBD	330a082d-57b2-2bf5-e054-00144ff88e88	2
308460	azithromycin 250 MG Oral Tablet	SCD	6307a49b-753a-4232-a51d-bf6d0537b05b	2
308460	azithromycin 250 MG Oral Tablet	SCD	6c4ce016-e728-4d9a-b1c9-ffd2a8d15607	2
308460	azithromycin 250 MG Oral Tablet	SCD	330a082d-57b2-2bf5-e054-00144ff88e88	2
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	6307a49b-753a-4232-a51d-bf6d0537b05b	2
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	6c4ce016-e728-4d9a-b1c9-ffd2a8d15607	2
212446	Zithromax 250 MG Oral Tablet	SY	330a082d-57b2-2bf5-e054-00144ff88e88	2
749780	{3 (azithromycin 500 MG Oral Tablet) } Pack	GPCK	eeea2ed3-ae33-4e88-abdf-dfcf85582d46	1
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	6fadde9e-dab3-4d01-b3fb-795eef7eff2f	1
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	eeea2ed3-ae33-4e88-abdf-dfcf85582d46	1
308460	azithromycin 250 MG Oral Tablet	PSN	6fadde9e-dab3-4d01-b3fb-795eef7eff2f	1
308460	azithromycin 250 MG Oral Tablet	PSN	9e5bb949-c9be-48cd-b0a2-6b7fd536e777	1
308460	azithromycin 250 MG Oral Tablet	PSN	eeea2ed3-ae33-4e88-abdf-dfcf85582d46	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	6fadde9e-dab3-4d01-b3fb-795eef7eff2f	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	eeea2ed3-ae33-4e88-abdf-dfcf85582d46	1
248656	azithromycin 500 MG Oral Tablet	PSN	6fadde9e-dab3-4d01-b3fb-795eef7eff2f	1
248656	azithromycin 500 MG Oral Tablet	PSN	eeea2ed3-ae33-4e88-abdf-dfcf85582d46	1
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	PSN	eeea2ed3-ae33-4e88-abdf-dfcf85582d46	1
308460	azithromycin 250 MG Oral Tablet	SCD	6fadde9e-dab3-4d01-b3fb-795eef7eff2f	1
308460	azithromycin 250 MG Oral Tablet	SCD	9e5bb949-c9be-48cd-b0a2-6b7fd536e777	1
308460	azithromycin 250 MG Oral Tablet	SCD	eeea2ed3-ae33-4e88-abdf-dfcf85582d46	1
248656	azithromycin 500 MG Oral Tablet	SCD	eeea2ed3-ae33-4e88-abdf-dfcf85582d46	1
248656	azithromycin 500 MG Oral Tablet	SCD	6fadde9e-dab3-4d01-b3fb-795eef7eff2f	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	eeea2ed3-ae33-4e88-abdf-dfcf85582d46	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	6fadde9e-dab3-4d01-b3fb-795eef7eff2f	1
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	6fadde9e-dab3-4d01-b3fb-795eef7eff2f	1
248656	azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet	SY	eeea2ed3-ae33-4e88-abdf-dfcf85582d46	1
749780	azithromycin 500 MG Oral Tablet 3 Count Pack	SY	eeea2ed3-ae33-4e88-abdf-dfcf85582d46	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64679-961-01	64679096101	30 TABLET, FILM COATED in 1 BOTTLE (64679-961-01)		2015-07-28	0000-00-00	No	No	Current
64679-961-02	64679096102	10 BLISTER PACK in 1 CARTON (64679-961-02) > 10 TABLET, FILM COATED in 1 BLISTER PACK (64679-961-09)	10 blister pack	2015-07-28	0000-00-00	No	No	Current
64679-961-05	64679096105	3 BLISTER PACK in 1 CARTON (64679-961-05) > 6 TABLET, FILM COATED in 1 BLISTER PACK (64679-961-04)	3 blister pack	2015-07-28	0000-00-00	No	No	Current
64679-961-07	64679096107	500 TABLET, FILM COATED in 1 BOTTLE (64679-961-07)		2015-07-28	0000-00-00	No	No	Current
64679-961-08	64679096108	3500 TABLET, FILM COATED in 1 BAG (64679-961-08)		2015-07-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Azithromycin	Wockhardt USA LLC. \| Vivimed Life Sciences Private Limited	2021-12-08	HUMAN PRESCRIPTION DRUG LABEL	9
Azithromycin	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	3
Azithromycin	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Azithromycin	AvPAK	2020-04-24	HUMAN PRESCRIPTION DRUG LABEL	20
AZITHROMYCIN 250mg	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
Azithromycin	Lake Erie Medical DBA Quality Care Products LLC	2019-11-13	HUMAN PRESCRIPTION DRUG LABEL	2
Azithromycin	A-S Medication Solutions	2018-04-16	HUMAN PRESCRIPTION DRUG LABEL	8
Azithromycin	Unit Dose Services	2017-11-07	HUMAN PRESCRIPTION DRUG LABEL	6
AZITHROMYCIN - RxChange Co.	RxChange Co.	2014-11-19	HUMAN PRESCRIPTION DRUG LABEL	2
AZITHROMYCIN 250MG AND 500MG TAB 6 PCK AND 3 PCK FOR WOCKHARDT	Aidarex Pharmaceuticals LLC	2013-12-12	HUMAN PRESCRIPTION DRUG LABEL	1
AZITHROMYCIN - H.J. Harkins Company, Inc.	H.J. Harkins Company, Inc.	2012-02-16	HUMAN PRESCRIPTION DRUG LABEL	2
AZITHROMYCIN - Dispensing Solutions, Inc.	Dispensing Solutions, Inc.	2011-09-06	HUMAN PRESCRIPTION DRUG LABEL	1
AZITHROMYCIN - Rebel Distributors Corp.	Rebel Distributors Corp.	2010-02-01	HUMAN PRESCRIPTION DRUG LABEL	1