Captopril

Product NDC: 27241-161
11-digit product format: 272410161
Labeler code: 27241
Product ID: 27241-161_6425b4dc-ff42-4118-88dd-c369924fc080
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Captopril
Dosage form: TABLET
Route: ORAL
Labeler: Ajanta Pharma USA Inc.
Application: ANDA212809
Marketing category: ANDA
Marketing start: 2019-12-13
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

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

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 · 156 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
2026-09-14 22:38:34	2026-08	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212809-001	CAPTOPRIL	12.5MG	TABLET / ORAL	AB	2019-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212809-002	CAPTOPRIL	25MG	TABLET / ORAL	AB	2019-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212809-003	CAPTOPRIL	50MG	TABLET / ORAL	AB	2019-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212809-004	CAPTOPRIL	100MG	TABLET / ORAL	AB	2019-12-13	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212809-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212809-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212809-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212809-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212809-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212809-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212809-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212809-004	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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
1fbc9b28-ff10-4b17-a359-e12b4330747e	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
27241-161-01	Captopril	100 in 1 BOTTLE	TABLET	100		3
27241-161-10	Captopril	1000 in 1 BOTTLE	TABLET	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27241-161-01	EA - Each	27241-161	0a4655dd-4e46-4870-b8af-bccf495cadcd	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27241-161	CAPTOPRIL TABLET [AJANTA PHARMA USA INC.]	2	Current NDC, Legacy NDC, 2 package rows	20211124_1fbc9b28-ff10-4b17-a359-e12b4330747e.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	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
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
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

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
317173	captopril 25 MG Oral Tablet	PSN	563737c5-4d63-4957-8022-e3bc3112dfac	103
317173	captopril 25 MG Oral Tablet	SCD	563737c5-4d63-4957-8022-e3bc3112dfac	103
308963	captopril 12.5 MG Oral Tablet	PSN	a43a5373-ded9-4912-8c98-edaec8352836	7
317173	captopril 25 MG Oral Tablet	PSN	a43a5373-ded9-4912-8c98-edaec8352836	7
308963	captopril 12.5 MG Oral Tablet	SCD	a43a5373-ded9-4912-8c98-edaec8352836	7
317173	captopril 25 MG Oral Tablet	SCD	a43a5373-ded9-4912-8c98-edaec8352836	7
308962	captopril 100 MG Oral Tablet	PSN	1fbc9b28-ff10-4b17-a359-e12b4330747e	3
308963	captopril 12.5 MG Oral Tablet	PSN	1fbc9b28-ff10-4b17-a359-e12b4330747e	3
317173	captopril 25 MG Oral Tablet	PSN	1fbc9b28-ff10-4b17-a359-e12b4330747e	3
308964	captopril 50 MG Oral Tablet	PSN	1fbc9b28-ff10-4b17-a359-e12b4330747e	3
308962	captopril 100 MG Oral Tablet	SCD	1fbc9b28-ff10-4b17-a359-e12b4330747e	3
308963	captopril 12.5 MG Oral Tablet	SCD	1fbc9b28-ff10-4b17-a359-e12b4330747e	3
317173	captopril 25 MG Oral Tablet	SCD	1fbc9b28-ff10-4b17-a359-e12b4330747e	3
308964	captopril 50 MG Oral Tablet	SCD	1fbc9b28-ff10-4b17-a359-e12b4330747e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27241-161-01	27241016101	100 TABLET in 1 BOTTLE (27241-161-01)	100 tablet	2019-12-13	0000-00-00	No	No	Current
27241-161-10	27241016110	1000 TABLET in 1 BOTTLE (27241-161-10)	1000 tablet	2019-12-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Captopril Tablets, USP Rx only	Bryant Ranch Prepack	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	103
Captopril Tablets, USP Rx only	Major Pharmaceuticals	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	7
Captopril Tablets, USP Rx only	Ajanta Pharma USA Inc. \| Ajanta Pharma Limited, Paithan	2025-11-27	Human Prescription Drug Label	3