FDA Orange Book · active-ingredient family
Captopril
Captopril: 1 brand, 26 generics; first approved Jan 17, 1985; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 26 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
26
Listed patents
0
Presentations
111
Brand (NDA) products
Originator applications
- CAPOTENRLDAARXION ANDA HLDINGNDA 01834319857 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 150MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued — 37.5MG TABLET ORAL Discontinued — 75MG TABLET ORAL Discontinued —
Generic (ANDA) products (26)
Abbreviated applications
- CAPTOPRILAIPING PHARM INCANDA 21444220234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - CAPTOPRILAJANTA PHARMA LTDANDA 21280920194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - CAPTOPRILSETON PHARMSANDA 21222320194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILCOREPHARMAANDA 07473719984 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - CAPTOPRILANDAS 5 HOLDINGANDA 07467719974 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 12.5MG TABLET ORAL Rx AB - CAPTOPRILEGIS PHARMSANDA 07474819974 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued — - CAPTOPRILPUREPAC PHARMANDA 07464019974 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILWOCKHARDT BIO AGANDA 07453219974 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - CAPTOPRILG AND W LABS INCANDA 07459019964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — 12.5MG TABLET ORAL Discontinued — - CAPTOPRILWATSON LABSANDA 07438619964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILWATSON LABSANDA 07457619964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILAUROBINDO PHARMA USAANDA 07443419964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILCHARTWELL RXANDA 07451919964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILCOSETTE PHARMS NCANDA 07443319964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILCOSETTE PHARMS NCANDA 07446219964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILCOSETTE PHARMS NCANDA 07448319964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILDAVA PHARMS INCANDA 07442319964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILHIKMA INTL PHARMSANDA 07450519964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - CAPTOPRILOXFORD PHARMSANDA 07441819964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILPRINSTON INCANDA 07447719964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - CAPTOPRILSANDOZANDA 07448119964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILSTRIDES PHARMA INTLANDA 07449319964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILTEVAANDA 07432219964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILWATSON LABSANDA 07445119964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILCHARTWELL RXANDA 07436319954 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued — - CAPTOPRILAPOTHECONANDA 07447219954 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 12.5MG TABLET ORAL Discontinued — 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — 100MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
42 yr 3 mo ago
Most recent approval
3 yr 8 mo ago
Approvals span 1985–2023 across 27 FDA applications.
Brand (NDA) 14%
Generic (ANDA) 2696%
Captopril: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
