Application 065398

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZITHROMYCIN	AZITHROMYCIN	TABLET;ORAL	EQ 250MG 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
A065398-001	AZITHROMYCIN	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB		2015-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065398-001	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	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065398-001	AZITHROMYCIN	EQ 250MG BASE	TABLET / ORAL	AB	2015-05-15	`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	A065398-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065398-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065398-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065398-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065398-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065398-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065398-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065398-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065398-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065398-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065398-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065398-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065398-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065398-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065398-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065398-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065398-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065398-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065398-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065398-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065398-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065398-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065398-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065398-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065398-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065398-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065398-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065398-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065398-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065398-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065398-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065398-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065398-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065398-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065398-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065398-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065398-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065398-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065398-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065398-001	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
azithromycin	AZITHROMYCIN	Coupler LLC	510024c9-6658-e08f-e063-6294a90a0793	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
azithromycin	AZITHROMYCIN	Cardinal Health 107, LLC	ea128124-8712-4998-be46-47d43ef127d4	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	01649d79-4677-4577-a3e4-e054f3f9fc3b	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398 ndc (product): 68180-861
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	da399401-1ee6-422a-be46-0bba6b264b2f	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
azithromycin	AZITHROMYCIN	Major Pharmaceuticals	814abe38-da4a-48af-bf4b-2ce04a5aabd1	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
Azithromycin	AZITHROMYCIN	American Health Packaging	6169e56c-10fb-448d-ab0f-14e54fcf2817	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
azithromycin	AZITHROMYCIN	Proficient Rx LP	25bc2e78-9d0d-41c6-a55e-a267d4457967	2025-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398
azithromycin dihydrate	AZITHROMYCIN DIHYDRATE	Advanced Rx of Tennessee, LLC	20ae108a-00c5-a984-e063-6394a90aaaae	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065398 application number: ANDA065398

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 49 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6708	azithromycin monohydrate	azithromycin monohydrate	Major Pharmaceuticals	ANDA	Current
0904-6708	azithromycin monohydrate	azithromycin monohydrate	Major Pharmaceuticals	ANDA	Current
0904-6708	azithromycin monohydrate	azithromycin monohydrate	Major Pharmaceuticals	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-728	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
53217-327	azithromycin monohydrate	azithromycin monohydrate	Aidarex Pharmaceuticals LLC	ANDA	Current
55154-8094	azithromycin monohydrate	azithromycin monohydrate	Cardinal Health	ANDA	Current
55154-8094	azithromycin monohydrate	azithromycin monohydrate	Cardinal Health 107, LLC	ANDA	Current
55154-8094	azithromycin monohydrate	azithromycin monohydrate	Cardinal Health 107, LLC	ANDA	Current
55700-432	azithromycin monohydrate	azithromycin monohydrate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
57297-160	azithromycin monohydrate	azithromycin monohydrate	LUPIN LIMITED	ANDA	Current
60687-282	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-282	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-282	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-282	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-282	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
61919-170	AZITHROMYCIN MONOHYDRATE	AZITHROMYCIN MONOHYDRATE	Direct_Rx	ANDA	Current
68071-3136	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3136	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4214	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4230	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68180-160	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-160	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-160	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-160	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-160	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-861	azithromycin dihydrate	azithromycin dihydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68788-7654	azithromycin monohydrate	azithromycin monohydrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7654	azithromycin monohydrate	azithromycin monohydrate	Preferred Pharmaceuticals, Inc.	ANDA	Current
69677-129	Azithromycin Monohydrate	Azithromycin Monohydrate	MAS MANAGEMENT GROUP, INC.	ANDA	Current
70518-0736	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0736	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0736	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0736	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0803	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0803	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0803	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0803	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
70518-0803	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current
71205-119	azithromycin monohydrate	azithromycin monohydrate	Proficient Rx LP	ANDA	Current
71205-119	azithromycin monohydrate	azithromycin monohydrate	Proficient Rx LP	ANDA	Current
71205-119	azithromycin monohydrate	azithromycin monohydrate	Proficient Rx LP	ANDA	Current
71205-427	azithromycin monohydrate	azithromycin monohydrate	Proficient Rx LP	ANDA	Current
71205-427	azithromycin monohydrate	azithromycin monohydrate	Proficient Rx LP	ANDA	Current