azithromycin monohydrate

Product NDC: 48792-7869
11-digit product format: 487927869
Labeler code: 48792
Product ID: 48792-7869_7d767e67-b16a-7276-e053-2991aa0a0609
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin monohydrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sunshine Lake Pharma Co., Ltd.
Application: ANDA209045
Marketing category: ANDA
Marketing start: 2018-12-20
Marketing end: 0000-00-00
Substance: AZITHROMYCIN MONOHYDRATE
Active strength: 250 mg/1
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	48792-7869		D	Discontinued by firm	2026-08-03
excluded product	product	48792-7869		D	Discontinued by firm	2026-08-03
excluded package	package	48792-7869	48792-7869-1	D	Discontinued by firm	2026-08-03
excluded package	package	48792-7869	48792-7869-4	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 · 58 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	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	48792-7869-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	48792-7869-4	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	48792-7869-4	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	48792-7869-4	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	48792-7869-4	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	48792-7869-4	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	48792-7869-4	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`4bd3596a7b87…`	`5c64c6f6865f…`

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
A209045-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB		2018-12-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209045-001	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	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209045-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2018-12-07	`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	A209045-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209045-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209045-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209045-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209045-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209045-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209045-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209045-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209045-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209045-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209045-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209045-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209045-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209045-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209045-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209045-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209045-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209045-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209045-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209045-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209045-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209045-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209045-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209045-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209045-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209045-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209045-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209045-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209045-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209045-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209045-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209045-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209045-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209045-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209045-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209045-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209045-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209045-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209045-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209045-001	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	Rising Pharma Holdings, Inc.	5199689f-8881-7757-e063-6394a90ae2eb	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209045 application number: ANDA209045
azithromycin	AZITHROMYCIN	Lannett Company, Inc.	a2b0c06b-e93d-f5aa-e053-2995a90ac9aa	2025-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209045 application number: ANDA209045

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JTE4MNN1MD	AZITHROMYCIN MONOHYDRATE	121470-24-4	AZITHROMYCIN MONOHYDRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
48792-7869-1	48792786901	30 TABLET, FILM COATED in 1 BOTTLE (48792-7869-1)	2018-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
azithromycin monohydrate	Sunshine Lake Pharma Co., Ltd.	2018-12-20	HUMAN PRESCRIPTION DRUG LABEL	1