Application 065212

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	TABLET;ORAL	EQ 500MG BASE	No	No

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
A065212-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG 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
A065212-001	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	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065212-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2005-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065212-001	AZITHROMYCIN	EQ 500MG 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	A065212-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065212-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065212-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065212-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065212-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065212-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065212-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065212-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065212-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065212-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065212-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065212-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065212-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065212-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065212-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065212-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065212-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065212-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065212-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065212-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065212-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065212-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065212-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065212-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065212-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065212-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065212-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065212-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065212-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065212-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065212-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065212-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065212-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065212-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065212-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065212-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065212-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065212-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065212-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065212-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Preferred Pharmaceuticals Inc.	661ff7a6-6394-493d-a307-a1f607e5d117	2026-06-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065212 application number: ANDA065212 ndc (product): 68788-8125
Azithromycin	AZITHROMYCIN	Proficient Rx LP	90605f94-93e1-43d1-8be7-830e816ac84f	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065212 application number: ANDA065212 ndc (product): 71205-674
Azithromycin	AZITHROMYCIN	Sandoz Inc	ec619299-e0ef-44dd-acdb-8c53bbfc5b8a	2022-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065212 application number: ANDA065212 ndc (product): 0781-8090

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-1941	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-5789	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-5789	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-5789	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-5789	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-8090	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-8090	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-8090	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
0781-8090	Azithromycin	Azithromycin	Sandoz Inc	ANDA	Current
43063-540	Azithromycin	Azithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-540	Azithromycin	Azithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-540	Azithromycin	Azithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-700	Azithromycin	Azithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-700	Azithromycin	Azithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-700	Azithromycin	Azithromycin	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
63187-622	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
63187-622	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
68788-7082	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7082	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7082	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7082	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8125	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8947	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8947	Azithromycin	Azithromycin	Preferred Pharmaceuticals Inc.	ANDA	Current
71205-196	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71205-196	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71205-196	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71205-674	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current