Azithromycin

Product NDC: 70518-2562
Requested package NDC: 70518-2562-1
11-digit product format: 705182562
Labeler code: 70518
Product ID: 70518-2562_ca3b3b52-71ff-4b55-e053-2995a90a1ac1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA210000
Marketing category: ANDA
Marketing start: 2020-02-04
Marketing end: 0000-00-00
Substance: AZITHROMYCIN DIHYDRATE
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2562	70518-2562-1	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A210000-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB		2019-02-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210000-001	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	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210000-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2019-02-26	`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	A210000-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210000-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210000-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210000-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210000-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210000-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210000-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210000-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210000-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210000-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210000-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210000-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210000-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210000-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210000-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210000-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210000-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210000-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210000-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210000-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210000-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210000-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210000-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210000-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210000-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210000-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210000-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210000-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210000-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210000-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210000-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210000-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210000-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210000-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210000-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210000-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210000-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210000-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210000-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210000-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70518-2562-0	2023-03-10	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
70518-2562-1	2023-03-10	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
70518-2562-2	2023-03-10	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
70518-2562-0	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
70518-2562-1	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
70518-2562-2	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

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	AvKARE	dc633b7d-5154-7e43-e053-2a95a90ad2a6	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	a5b4092d-ab72-f5d1-e053-2995a90ac582	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
Azithromycin	AZITHROMYCIN	Bionpharma Inc.	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	b0138503-ddc4-2e1c-e053-2995a90a0d2d	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	b77b347d-d357-4bdf-b985-49d9a1dd634c	2023-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
Azithromycin	AZITHROMYCIN	A-S Medication Solutions	af720986-48a9-48b5-bdd7-370f6a2f92e1	2023-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
Azithromycin	AZITHROMYCIN	Proficient Rx LP	99ca0089-14a9-446d-8807-253ad5be3efa	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000
Azithromycin	AZITHROMYCIN	Doc Rx	90ff7cfc-73c9-4d77-83df-c05cfbbbbecd	2021-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210000 application number: ANDA210000

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	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2562-1	70518256201	6 TABLET, FILM COATED in 1 BLISTER PACK (70518-2562-1)	2020-02-17	0000-00-00	No	No	Current