FDA Orange Book
Generic for Lotensin
Lotensin contains benazepril. 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 Lotensin is benazepril. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lotensin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 20MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 40MG | Marketed (Rx) | AB | 10 | AB |
| tablet, oral | 5MG | Discontinued | None | 9 | AB |
NDA 019851, held by VALIDUS PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic benazepril
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANI PHARMACEUTICALS INC | 076333 | AB (A-rated, therapeutically equivalent) | February 11, 2004 | 10MG, 20MG, 40MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 076402 | AB (A-rated, therapeutically equivalent) | February 11, 2004 | 10MG, 20MG, 40MG, 5MG |
| HERITAGE PHARMA LABS INC | 076267 | AB (A-rated, therapeutically equivalent) | February 11, 2004 | 10MG, 20MG, 40MG, 5MG |
| PRINSTON PHARMACEUTICAL INC | 076118 | AB (A-rated, therapeutically equivalent) | February 11, 2004 | 10MG, 20MG, 40MG, 5MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 076344 | AB (A-rated, therapeutically equivalent) | February 11, 2004 | 10MG, 20MG, 40MG, 5MG |
| TEVA PHARMACEUTICALS USA INC | 076211 | AB (A-rated, therapeutically equivalent) | February 11, 2004 | 10MG, 20MG, 40MG, 5MG |
| AMNEAL PHARMACEUTICALS OF NEW YORK LLC | 076820 | AB (A-rated, therapeutically equivalent) | February 3, 2006 | 10MG, 20MG, 40MG, 5MG |
| MACLEODS PHARMACEUTICALS LTD | 077128 | AB (A-rated, therapeutically equivalent) | March 8, 2006 | 10MG, 20MG, 40MG, 5MG |
| AUROBINDO PHARMA LTD | 078212 | AB (A-rated, therapeutically equivalent) | May 22, 2008 | 10MG, 20MG, 40MG |
| ZYDUS LIFESCIENCES LTD | 078848 | AB (A-rated, therapeutically equivalent) | May 23, 2008 | 10MG, 20MG, 40MG, 5MG |
Lotensin NDC codes
Questions
Is there a generic for Lotensin?
Yes. The generic name for Lotensin is benazepril. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Lotensin?
The active ingredient in Lotensin is benazepril, 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.