FDA Orange Book
Generic for Altace
Altace contains ramipril. 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 Altace is ramipril. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 8 Altace products the Orange Book lists.
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Altace products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 1.25MG | Discontinued | None | 8 | AB |
| capsule, oral | 10MG | Discontinued | None | 8 | AB |
| capsule, oral | 2.5MG | Discontinued | None | 8 | AB |
| capsule, oral | 5MG | Discontinued | None | 7 | AB |
| tablet, oral | 1.25MG | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Discontinued | None | 0 | None |
| tablet, oral | 2.5MG | Discontinued | None | 0 | None |
| tablet, oral | 5MG | Discontinued | None | 0 | None |
NDA 019901, 022021, held by KING PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ramipril
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| WATSON LABORATORIES INC | 076549 | AB (A-rated, therapeutically equivalent) | October 24, 2005 | 1.25MG, 10MG, 2.5MG |
| LUPIN LTD | 077626 | AB (A-rated, therapeutically equivalent) | June 9, 2008 | 1.25MG, 10MG, 2.5MG, 5MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 078745 | AB (A-rated, therapeutically equivalent) | June 18, 2008 | 1.25MG, 10MG, 2.5MG, 5MG |
| HIKMA PHARMACEUTICALS USA INC | 077900 | AB (A-rated, therapeutically equivalent) | June 18, 2008 | 1.25MG, 10MG, 2.5MG, 5MG |
| PHARMAZONE | 078191 | AB (A-rated, therapeutically equivalent) | June 18, 2008 | 1.25MG, 10MG, 2.5MG, 5MG |
| SOLGEN PHARMA LLC | 079116 | AB (A-rated, therapeutically equivalent) | June 20, 2008 | 1.25MG, 10MG, 2.5MG, 5MG |
| ZYDUS PHARMACEUTICALS USA INC | 078832 | AB (A-rated, therapeutically equivalent) | September 2, 2008 | 1.25MG, 10MG, 2.5MG, 5MG |
| AUROBINDO PHARMA LTD | 091604 | AB (A-rated, therapeutically equivalent) | June 8, 2011 | 1.25MG, 10MG, 2.5MG, 5MG |
Questions
Is there a generic for Altace?
Yes. The generic name for Altace is ramipril. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 8 Altace products the Orange Book lists.
What is the generic name for Altace?
The active ingredient in Altace is ramipril, 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.