Application 212809

Type: ANDA
Sponsor: AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	12.5MG	No	No
002	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	25MG	No	No
003	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	50MG	No	No
004	CAPTOPRIL	CAPTOPRIL	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212809-001	CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13
A212809-002	CAPTOPRIL	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13
A212809-003	CAPTOPRIL	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13
A212809-004	CAPTOPRIL	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A212809-001	AB
A212809-002	AB
A212809-003	AB
A212809-004	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 4 · 148 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	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 148 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	A212809-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212809-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212809-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212809-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212809-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212809-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212809-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212809-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212809-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212809-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212809-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212809-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212809-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212809-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212809-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212809-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212809-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212809-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212809-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212809-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212809-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212809-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212809-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212809-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212809-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212809-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212809-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212809-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212809-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212809-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212809-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212809-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212809-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212809-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212809-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212809-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212809-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212809-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212809-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212809-004	AB	1	`d06236e962d9…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Captopril	CAPTOPRIL	Bryant Ranch Prepack	563737c5-4d63-4957-8022-e3bc3112dfac	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212809 application number: ANDA212809 ndc (product): 71335-1918
Captopril	CAPTOPRIL	Bryant Ranch Prepack	66604c8e-f6b6-4cf9-9561-f1cb4af0e0d6	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212809 application number: ANDA212809
Captopril	CAPTOPRIL	Major Pharmaceuticals	a43a5373-ded9-4912-8c98-edaec8352836	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212809 application number: ANDA212809 ndc (product): 0904-7105 ndc (product): 0904-7106
Captopril	CAPTOPRIL	Ajanta Pharma USA Inc.	1fbc9b28-ff10-4b17-a359-e12b4330747e	2025-11-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212809 application number: ANDA212809 ndc (product): 27241-161 ndc (product): 27241-160 ndc (product): 27241-162 ndc (product): 27241-163

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7105	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
0904-7106	Captopril	Captopril	Major Pharmaceuticals	ANDA	Current
27241-160	Captopril	Captopril	Ajanta Pharma Limited	ANDA	Current
27241-160	Captopril	Captopril	Ajanta Pharma USA Inc.	ANDA	Current
27241-161	Captopril	Captopril	Ajanta Pharma Limited	ANDA	Current
27241-161	Captopril	Captopril	Ajanta Pharma USA Inc.	ANDA	Current
27241-162	Captopril	Captopril	Ajanta Pharma Limited	ANDA	Current
27241-162	Captopril	Captopril	Ajanta Pharma USA Inc.	ANDA	Current
27241-163	Captopril	Captopril	Ajanta Pharma Limited	ANDA	Current
27241-163	Captopril	Captopril	Ajanta Pharma USA Inc.	ANDA	Current
70518-3307	Captopril	Captopril	REMEDYREPACK INC.	ANDA	Current
71335-1918	Captopril	Captopril	Bryant Ranch Prepack	ANDA	Current
71335-1918	Captopril	Captopril	Bryant Ranch Prepack	ANDA	Current