Application 074737

Type: ANDA
Sponsor: COREPHARMA

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 42.

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
A074737-001	CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1998-10-28
A074737-002	CAPTOPRIL	CAPTOPRIL	25MG	TABLET / ORAL	AB	1998-10-28
A074737-003	CAPTOPRIL	CAPTOPRIL	50MG	TABLET / ORAL	AB	1998-10-28
A074737-004	CAPTOPRIL	CAPTOPRIL	100MG	TABLET / ORAL	AB	1998-10-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074737-001	AB
A074737-002	AB
A074737-003	AB
A074737-004	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 5 · 168 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
2026-08-18 06:07:40	2026-07	A074737-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1998-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074737-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1998-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074737-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	1998-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074737-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	1998-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074737-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1998-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074737-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1998-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074737-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	1998-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074737-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	1998-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074737-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1998-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074737-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1998-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074737-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	1998-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074737-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	1998-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074737-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1998-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074737-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1998-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074737-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	1998-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074737-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	1998-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074737-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1998-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074737-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1998-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074737-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	1998-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074737-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	1998-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074737-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1998-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074737-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1998-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074737-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	1998-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074737-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	1998-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074737-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1998-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074737-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1998-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074737-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	1998-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074737-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	1998-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074737-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1998-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074737-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1998-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074737-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	1998-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074737-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	1998-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074737-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1998-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074737-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1998-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074737-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	1998-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074737-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	1998-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074737-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	1998-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074737-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	1998-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074737-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	1998-10-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074737-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	1998-10-28	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 136 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074737-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074737-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074737-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074737-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074737-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074737-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074737-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074737-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074737-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074737-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074737-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074737-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074737-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074737-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074737-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074737-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074737-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074737-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074737-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074737-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074737-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074737-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074737-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074737-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074737-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074737-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074737-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074737-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074737-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074737-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074737-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074737-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074737-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074737-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074737-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074737-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074737-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074737-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074737-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074737-004	AB	1	`d8e5a09893c0…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Captopril	CAPTOPRIL	AvKARE	3362b7a8-026a-b277-e063-6394a90a9dc6	2025-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074737 application number: ANDA074737
Captopril	CAPTOPRIL	Camber Pharmaceuticals, Inc.	5b44ab6e-6cd9-4e12-b9be-d2e4d954acb5	2023-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074737 application number: ANDA074737 ndc (product): 31722-144 ndc (product): 31722-143 ndc (product): 31722-141 ndc (product): 31722-142

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-141	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-141	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-141	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-141	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-142	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-142	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-142	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-142	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-143	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-143	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-143	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-143	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-144	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-144	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-144	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-144	Captopril	Captopril	Camber Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8439	ORIG	1998-10-28