Azithromycin

Product NDC: 68071-2622
11-digit product format: 680712622
Labeler code: 68071
Product ID: 68071-2622_d5f4c2a2-6ffa-345c-e053-2995a90ae414
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Azithromycin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA065225
Marketing category: ANDA
Marketing start: 2006-01-06
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2622		I	Inactivated by FDA		2026-08-03
excluded package	package	68071-2622	68071-2622-6	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 1 · 18 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2622-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2622-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2622-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2622-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2622-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2622-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2622-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2622-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2622-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A065225-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB		2005-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065225-001	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	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065225-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2005-11-14	`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	A065225-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065225-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065225-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065225-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065225-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065225-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065225-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065225-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065225-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065225-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065225-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065225-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065225-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065225-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065225-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065225-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065225-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065225-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065225-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065225-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065225-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065225-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065225-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065225-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065225-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065225-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065225-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065225-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065225-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065225-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065225-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065225-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065225-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065225-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065225-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065225-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065225-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065225-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065225-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065225-001	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2622-6	2025-01-30	C162847	48780-1	2cef2736-890f-d83d-e063-dadaa90ab31f	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	Strength	SPL version
68071-2622-6	Azithromycin	6 in 1 BLISTER PACK	TABLET, FILM COATED	6		1
68071-2622-6	Azithromycin	1 in 1 CARTON	TABLET, FILM COATED	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2622	AZITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 2 package rows	20220120_d5f4c2a2-6ff9-345c-e053-2995a90ae414.zip

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	333ffe63-aaeb-4dff-b595-1c11209189a6	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065225 application number: ANDA065225
Azithromycin	AZITHROMYCIN	Sportpharm LLC	5f9e13f5-69ee-4220-90d9-31fa8660d880	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065225 application number: ANDA065225
Azithromycin	AZITHROMYCIN	Advanced Rx Pharmacy of Tennessee, LLC	f175496a-4ad3-ce0d-e053-2a95a90a6613	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065225 application number: ANDA065225
Azithromycin	AZITHROMYCIN	Asclemed USA, Inc.	9c44af6d-8a9a-cb4c-e053-2a95a90afdac	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065225 application number: ANDA065225
Azithromycin	AZITHROMYCIN	Teva Pharmaceuticals USA, Inc.	f6a52c0b-45db-422e-8c22-e867a11b4439	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065225 application number: ANDA065225
Azithromycin	AZITHROMYCIN MONOHYDRATE	PharmPak, Inc.	ba57ff26-cd02-4f57-ac92-b613d245a4ea	2022-10-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065225 application number: ANDA065225
Azithromycin	AZITHROMYCIN	Proficient Rx LP	7e7c2f49-449c-4ba2-98ae-0ff0c040614c	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065225 application number: ANDA065225

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
749783	{6 (azithromycin 250 MG Oral Tablet) } Pack	GPCK	d5f4c2a2-6ff9-345c-e053-2995a90ae414	1
308460	azithromycin 250 MG Oral Tablet	PSN	d5f4c2a2-6ff9-345c-e053-2995a90ae414	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	PSN	d5f4c2a2-6ff9-345c-e053-2995a90ae414	1
308460	azithromycin 250 MG Oral Tablet	SCD	d5f4c2a2-6ff9-345c-e053-2995a90ae414	1
749783	azithromycin 250 MG Oral Tablet 6 Count Pack	SY	d5f4c2a2-6ff9-345c-e053-2995a90ae414	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2622-6	68071262206	1 BLISTER PACK in 1 CARTON (68071-2622-6) > 6 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2022-01-19	0000-00-00	No	No	Current