Application 018343

Type: NDA
Sponsor: PAR PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAPOTEN	CAPTOPRIL	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CAPOTEN	CAPTOPRIL	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	CAPOTEN	CAPTOPRIL	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	CAPOTEN	CAPTOPRIL	TABLET;ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	CAPOTEN	CAPTOPRIL	TABLET;ORAL	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
006	CAPOTEN	CAPTOPRIL	TABLET;ORAL	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
007	CAPOTEN	CAPTOPRIL	TABLET;ORAL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N018343-001	CAPOTEN	CAPTOPRIL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N018343-002	CAPOTEN	CAPTOPRIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N018343-003	CAPOTEN	CAPTOPRIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982
N018343-004	CAPOTEN	CAPTOPRIL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13
N018343-005	CAPOTEN	CAPTOPRIL	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-01-17
N018343-006	CAPOTEN	CAPTOPRIL	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-09-17
N018343-007	CAPOTEN	CAPTOPRIL	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13

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 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018343-001	CAPOTEN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018343-002	CAPOTEN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018343-003	CAPOTEN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018343-004	CAPOTEN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018343-005	CAPOTEN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018343-006	CAPOTEN	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018343-007	CAPOTEN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018343-001	CAPOTEN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018343-002	CAPOTEN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018343-003	CAPOTEN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018343-004	CAPOTEN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018343-005	CAPOTEN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018343-006	CAPOTEN	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-09-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018343-007	CAPOTEN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018343-001	CAPOTEN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018343-002	CAPOTEN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018343-003	CAPOTEN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018343-004	CAPOTEN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018343-005	CAPOTEN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018343-006	CAPOTEN	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018343-007	CAPOTEN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018343-001	CAPOTEN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018343-002	CAPOTEN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018343-003	CAPOTEN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018343-004	CAPOTEN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018343-005	CAPOTEN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018343-006	CAPOTEN	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018343-007	CAPOTEN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018343-001	CAPOTEN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018343-002	CAPOTEN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018343-003	CAPOTEN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018343-004	CAPOTEN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018343-005	CAPOTEN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018343-006	CAPOTEN	37.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018343-007	CAPOTEN	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018343-001	CAPOTEN	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018343-002	CAPOTEN	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018343-003	CAPOTEN	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018343-004	CAPOTEN	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1995-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018343-005	CAPOTEN	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1985-01-17	`fd3edfee7708…`

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
captopril	CAPTOPRIL	AMICI PHARMA, INC.	1395ba5b-2fc9-41ff-9c43-e0740d781dee	2026-09-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	Bryant Ranch Prepack	563737c5-4d63-4957-8022-e3bc3112dfac	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	Bryant Ranch Prepack	66604c8e-f6b6-4cf9-9561-f1cb4af0e0d6	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	Major Pharmaceuticals	a43a5373-ded9-4912-8c98-edaec8352836	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	AiPing Pharmaceutical, Inc.	3b789f16-b291-4012-be39-af3beec3ff9a	2026-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	Solco Healthcare US, LLC	2d3779b0-83d9-4b6f-a043-f7768cd7fce6	2025-12-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
captopril	CAPTOPRIL	Method Pharmaceuticals LLC	1a91ac7f-b75d-d111-e063-6394a90a2a93	2025-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	Ajanta Pharma USA Inc.	1fbc9b28-ff10-4b17-a359-e12b4330747e	2025-11-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	Golden State Medical Supply, Inc.	d117c8bd-50a8-7355-e053-2a95a90ac70f	2025-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
captopril	CAPTOPRIL	Bryant Ranch Prepack	ccbffd30-4b21-4522-bdb8-abba8d592017	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	AvKARE	3362b7a8-026a-b277-e063-6394a90a9dc6	2025-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	PD-Rx Pharmaceuticals, Inc.	65ed6e70-f1ee-437e-965c-d1b1fdadd832	2025-03-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	Hikma Pharmaceuticals USA Inc.	607687f4-63cf-411c-a20b-21d238a6b7a7	2024-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	American Health Packaging	9b54feb0-13cd-46a8-9924-f12880381196	2024-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL
Captopril	CAPTOPRIL	Camber Pharmaceuticals, Inc.	5b44ab6e-6cd9-4e12-b9be-d2e4d954acb5	2023-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CAPTOPRIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49226	SUPPL	2017-08-03
49217	SUPPL	2017-08-02
33483	SUPPL	2015-06-22
14991	SUPPL	2015-06-22
33482	SUPPL	2015-01-09
904	SUPPL	2014-12-30
903	SUPPL	2012-08-29
11210	SUPPL	2012-08-28
902	SUPPL	2011-12-15
33481	SUPPL	2011-12-14
14990	SUPPL	2011-05-24
33480	SUPPL	2011-05-23
14989	SUPPL	2008-09-29
44022	ORIG	2006-06-09
901	SUPPL	2004-05-07