FDA Orange Book
Generic for Capoten
Capoten contains captopril. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Capoten is captopril. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 7 Capoten products the Orange Book lists.
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Capoten products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 7 | AB |
| tablet, oral | 12.5MG | Discontinued | None | 7 | AB |
| tablet, oral | 150MG | Discontinued | None | 0 | None |
| tablet, oral | 25MG | Discontinued | None | 7 | AB |
| tablet, oral | 37.5MG | Discontinued | None | 0 | None |
| tablet, oral | 50MG | Discontinued | None | 7 | AB |
| tablet, oral | 75MG | Discontinued | None | 0 | None |
NDA 018343, held by AARXION ANDA HOLDING LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic captopril
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 074505 | AB (A-rated, therapeutically equivalent) | February 13, 1996 | 100MG, 12.5MG, 25MG, 50MG |
| PRINSTON PHARMACEUTICAL INC | 074477 | AB (A-rated, therapeutically equivalent) | February 13, 1996 | 100MG, 12.5MG, 25MG, 50MG |
| WOCKHARDT BIO AG | 074532 | AB (A-rated, therapeutically equivalent) | March 28, 1997 | 100MG, 12.5MG, 25MG, 50MG |
| ANDAS 5 HOLDING LLC | 074677 | AB (A-rated, therapeutically equivalent) | May 30, 1997 | 100MG, 12.5MG, 25MG, 50MG |
| MACLEODS PHARMACEUTICALS LTD | 074737 | AB (A-rated, therapeutically equivalent) | October 28, 1998 | 100MG, 12.5MG, 25MG, 50MG |
| AJANTA PHARMA LTD | 212809 | AB (A-rated, therapeutically equivalent) | December 13, 2019 | 100MG, 12.5MG, 25MG, 50MG |
| AIPING PHARMACEUTICAL INC | 214442 | AB (A-rated, therapeutically equivalent) | January 27, 2023 | 100MG, 12.5MG, 25MG, 50MG |
Questions
Is there a generic for Capoten?
Yes. The generic name for Capoten is captopril. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 7 Capoten products the Orange Book lists.
What is the generic name for Capoten?
The active ingredient in Capoten is captopril, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.