Application 210001

Type: ANDA
Sponsor: BIONPHARMA INC

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
A210001-001	AZITHROMYCIN	AZITHROMYCIN	EQ 500MG 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
A210001-001	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	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210001-001	AZITHROMYCIN	EQ 500MG BASE	TABLET / ORAL	AB	2019-02-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210001-001	AZITHROMYCIN	EQ 500MG 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	A210001-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210001-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210001-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210001-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210001-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210001-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210001-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210001-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210001-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210001-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210001-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210001-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210001-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210001-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210001-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210001-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210001-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210001-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210001-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210001-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210001-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210001-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210001-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210001-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210001-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210001-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210001-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210001-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210001-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210001-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210001-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210001-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210001-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210001-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210001-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210001-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210001-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210001-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210001-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210001-001	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Azithromycin	AZITHROMYCIN	Bryant Ranch Prepack	b5d79719-b1dc-469f-a19c-f8ba615138f0	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001 ndc (product): 71335-1755
Azithromycin	AZITHROMYCIN	AvKARE	dc633b7d-5154-7e43-e053-2a95a90ad2a6	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001 ndc (product): 42291-083
AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	a5b4092d-ab72-f5d1-e053-2995a90ac582	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001 ndc (product): 72189-088
Azithromycin	AZITHROMYCIN	Bionpharma Inc.	859bb02c-a4bc-46fa-9fc9-def1219b5dfb	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001 ndc (product): 69452-172
Azithromycin	AZITHROMYCIN	NuCare Pharmaceuticals,Inc.	b43d23c7-1a2e-ce93-e053-2995a90a65a4	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001 ndc (product): 68071-2297
Azithromycin	AZITHROMYCIN	Proficient Rx LP	34e6364a-ac3d-434e-a90c-cb13ebcf7983	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210001 application number: ANDA210001 ndc (product): 71205-503

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-083	Azithromycin	Azithromycin	AvKARE	ANDA	Current
43986-007	Azithromycin	Azithromycin	Bluepharma - Industria Farmaceutica, S.A.	ANDA	Current
68071-2297	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2297	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2507	Azithromycin	Azithromycin	NuCare Pharmaceuticals,Inc.	ANDA	Current
69452-172	Azithromycin	Azithromycin	Bionpharma Inc.	ANDA	Current
69452-172	Azithromycin	Azithromycin	Bionpharma Inc.	ANDA	Current
70518-3169	Azithromycin	Azithromycin	REMEDYREPACK INC.	ANDA	Current
71205-503	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71205-503	Azithromycin	Azithromycin	Proficient Rx LP	ANDA	Current
71335-1755	Azithromycin	Azithromycin	Bryant Ranch Prepack	ANDA	Current
72189-088	AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	ANDA	Current
72189-088	AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	ANDA	Current
72189-088	AZITHROMYCIN	AZITHROMYCIN	DIRECT RX	ANDA	Current