Captopril

Product NDC: 51407-601
Requested package NDC: 51407-601-10
11-digit product format: 514070601
Labeler code: 51407
Product ID: 51407-601_44734089-785c-b5ab-e063-6394a90ad162
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Captopril
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA074505
Marketing category: ANDA
Marketing start: 1996-02-13
Substance: CAPTOPRIL
Active strength: 25 mg/1
Pharmacologic classes: Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51407-601	51407-601-10	D	Discontinued by firm		2026-08-17

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	RLD / RS	Approval date
A074505-001	CAPTOPRIL	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13
A074505-002	CAPTOPRIL	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13
A074505-003	CAPTOPRIL	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13
A074505-004	CAPTOPRIL	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074505-001	AB
A074505-002	AB
A074505-003	AB
A074505-004	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB		1996-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-002	CAPTOPRIL	25MG	TABLET / ORAL	AB		1996-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-003	CAPTOPRIL	50MG	TABLET / ORAL	AB		1996-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	RS	1996-02-13	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A074505-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074505-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074505-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074505-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074505-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074505-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074505-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074505-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074505-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074505-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074505-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074505-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074505-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Captopril
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CAPTOPRIL	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9G64RSX1XD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308962	Internal RxNorm lookup
308963	Internal RxNorm lookup
308964	Internal RxNorm lookup
317173	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d117c8bd-50a8-7355-e053-2a95a90ac70f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5efca61-58ec-b4d0-77f8-f2b1fb112156	Product name	4	20240223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51407-601-01	Captopril	100 in 1 BOTTLE	TABLET	100		5
51407-601-10	Captopril	1000 in 1 BOTTLE	TABLET	1000		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-601-01	EA - Each	51407-601	780a3f64-32c0-4da8-a86d-105d9f07dcdb	1	2022-01-06
51407-601-10	EA - Each	51407-601	303817e6-3a67-4536-9ab1-5069050b4bfd	1	2022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-601	CAPTOPRIL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]	4	Current NDC, Legacy NDC, 2 package rows	20250119_d117c8bd-50a8-7355-e053-2a95a90ac70f.zip

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	Golden State Medical Supply, Inc.	d117c8bd-50a8-7355-e053-2a95a90ac70f	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505 ndc (package): 51407-601-10 ndc (product): 51407-601 ndc11 (package): 51407060110
Captopril	CAPTOPRIL	PD-Rx Pharmaceuticals, Inc.	65ed6e70-f1ee-437e-965c-d1b1fdadd832	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505
Captopril	CAPTOPRIL	Hikma Pharmaceuticals USA Inc.	607687f4-63cf-411c-a20b-21d238a6b7a7	2024-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505
Captopril	CAPTOPRIL	American Health Packaging	9b54feb0-13cd-46a8-9924-f12880381196	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074505 application number: ANDA074505

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9G64RSX1XD	CAPTOPRIL	62571-86-2	CAPTOPRIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308962	captopril 100 MG Oral Tablet	PSN	d117c8bd-50a8-7355-e053-2a95a90ac70f	5
308963	captopril 12.5 MG Oral Tablet	PSN	d117c8bd-50a8-7355-e053-2a95a90ac70f	5
317173	captopril 25 MG Oral Tablet	PSN	d117c8bd-50a8-7355-e053-2a95a90ac70f	5
308964	captopril 50 MG Oral Tablet	PSN	d117c8bd-50a8-7355-e053-2a95a90ac70f	5
308962	captopril 100 MG Oral Tablet	SCD	d117c8bd-50a8-7355-e053-2a95a90ac70f	5
308963	captopril 12.5 MG Oral Tablet	SCD	d117c8bd-50a8-7355-e053-2a95a90ac70f	5
317173	captopril 25 MG Oral Tablet	SCD	d117c8bd-50a8-7355-e053-2a95a90ac70f	5
308964	captopril 50 MG Oral Tablet	SCD	d117c8bd-50a8-7355-e053-2a95a90ac70f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-601-10	51407060110	1000 TABLET in 1 BOTTLE (51407-601-10)	1000 tablet	2021-09-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CAPTOPRIL TABLETS, USP Rev. 08/24 Rx only	Golden State Medical Supply, Inc.	2025-11-25	HUMAN PRESCRIPTION DRUG LABEL	5