Application 065399

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 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
A065399-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG 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
A065399-001	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	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065399-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2015-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065399-001	AZITHROMYCIN	EQ 500MG 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	A065399-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065399-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065399-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065399-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065399-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065399-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065399-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065399-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065399-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065399-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065399-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065399-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065399-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065399-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065399-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065399-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065399-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065399-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065399-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065399-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065399-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065399-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065399-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065399-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065399-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065399-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065399-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065399-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065399-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065399-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065399-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065399-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065399-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065399-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065399-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065399-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065399-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065399-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065399-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065399-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
azithromycin	AZITHROMYCIN	Lupin Pharmaceuticals, Inc.	01649d79-4677-4577-a3e4-e054f3f9fc3b	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065399 application number: ANDA065399 ndc (product): 68180-862
azithromycin	AZITHROMYCIN	REMEDYREPACK INC.	bf061799-cdef-40f8-b1ce-bc5eb609f8c3	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065399 application number: ANDA065399
azithromycin	AZITHROMYCIN	Major Pharmaceuticals	814abe38-da4a-48af-bf4b-2ce04a5aabd1	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065399 application number: ANDA065399
Azithromycin	AZITHROMYCIN	American Health Packaging	6169e56c-10fb-448d-ab0f-14e54fcf2817	2025-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065399 application number: ANDA065399
azithromycin dihydrate	AZITHROMYCIN DIHYDRATE	Advanced Rx of Tennessee, LLC	1cec44fa-9597-3e58-e063-6394a90ae326	2024-07-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065399 application number: ANDA065399

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6909	azithromycin monohydrate	azithromycin monohydrate	Major Pharmaceuticals	ANDA	Current
43063-713	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-713	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-713	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-713	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-713	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-713	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-713	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-715	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-715	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-715	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-715	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-715	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-715	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-715	azithromycin monohydrate	azithromycin monohydrate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2334	azithromycin dihydrate	azithromycin dihydrate	A-S Medication Solutions	ANDA	Current
50436-3136	azithromycin monohydrate	azithromycin monohydrate	Unit Dose Services	ANDA	Current
53002-3221	azithromycin monohydrate	azithromycin monohydrate	RPK Pharmaceuticals, Inc.	ANDA	Current
53217-403	azithromycin monohydrate	azithromycin monohydrate	Aidarex Pharmaceuticals LLC	ANDA	Current
55700-832	azithromycin monohydrate	azithromycin monohydrate	Quality Care Products, LLC	ANDA	Current
57297-161	azithromycin monohydrate	azithromycin monohydrate	LUPIN LIMITED	ANDA	Current
60687-271	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-271	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-271	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-271	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
60687-271	Azithromycin Monohydrate	Azithromycin Monohydrate	American Health Packaging	ANDA	Current
61919-096	AZITHROMYCIN MONOHYDRATE	AZITHROMYCIN MONOHYDRATE	DIRECT RX	ANDA	Current
61919-096	AZITHROMYCIN MONOHYDRATE	AZITHROMYCIN MONOHYDRATE	DIRECT RX	ANDA	Current
68071-3168	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3169	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3169	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-3187	azithromycin monohydrate	azithromycin monohydrate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68180-161	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-161	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-161	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-161	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-161	azithromycin monohydrate	azithromycin monohydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-862	azithromycin dihydrate	azithromycin dihydrate	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-3453	azithromycin monohydrate	azithromycin monohydrate	REMEDYREPACK INC.	ANDA	Current