FDA Orange Book
Generic for Lotrel
Lotrel contains amlodipine and 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 Lotrel is amlodipine and benazepril. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lotrel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 10MG BASE;20MG | Discontinued | None | 5 | AB |
| capsule, oral | EQ 10MG BASE;40MG | Discontinued | None | 5 | AB |
| capsule, oral | EQ 2.5MG BASE;10MG | Discontinued | None | 5 | AB |
| capsule, oral | EQ 5MG BASE;10MG | Discontinued | None | 5 | AB |
| capsule, oral | EQ 5MG BASE;20MG | Discontinued | None | 5 | AB |
| capsule, oral | EQ 5MG BASE;40MG | Discontinued | None | 5 | AB |
NDA 020364, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amlodipine and benazepril
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LUPIN PHARMACEUTICALS INC | 078466 | AB (A-rated, therapeutically equivalent) | February 5, 2010 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 2.5MG BASE;10MG, EQ 5MG BASE;10MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
| DR REDDYS LABORATORIES INC | 077183 | AB (A-rated, therapeutically equivalent) | April 15, 2010 | EQ 10MG BASE;20MG, EQ 2.5MG BASE;10MG, EQ 5MG BASE;10MG, EQ 5MG BASE;20MG |
| WATSON LABORATORIES INC | 077890 | AB (A-rated, therapeutically equivalent) | October 14, 2010 | EQ 10MG BASE;20MG, EQ 2.5MG BASE;10MG, EQ 5MG BASE;10MG, EQ 5MG BASE;20MG |
| DR REDDYS LABORATORIES INC | 090149 | AB (A-rated, therapeutically equivalent) | July 5, 2011 | EQ 10MG BASE;40MG, EQ 5MG BASE;40MG |
| WATSON LABORATORIES INC | 090364 | AB (A-rated, therapeutically equivalent) | July 5, 2011 | EQ 10MG BASE;40MG, EQ 5MG BASE;40MG |
| AUROBINDO PHARMA LTD | 202239 | AB (A-rated, therapeutically equivalent) | September 5, 2012 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 2.5MG BASE;10MG, EQ 5MG BASE;10MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 091431 | AB (A-rated, therapeutically equivalent) | December 30, 2013 | EQ 10MG BASE;20MG, EQ 10MG BASE;40MG, EQ 2.5MG BASE;10MG, EQ 5MG BASE;10MG, EQ 5MG BASE;20MG, EQ 5MG BASE;40MG |
Questions
Is there a generic for Lotrel?
Yes. The generic name for Lotrel is amlodipine and benazepril. 5 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 Lotrel?
The active ingredient in Lotrel is amlodipine and 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.