FDA Orange Book
Generic for Lotensin HCT
Lotensin HCT contains benazepril and hydrochlorothiazide. 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 HCT is benazepril and hydrochlorothiazide. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lotensin HCT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG;12.5MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 20MG;12.5MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 20MG;25MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 5MG;6.25MG | Discontinued | None | 2 | AB |
NDA 020033, 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 and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANI PHARMACEUTICALS INC | 076342 | AB (A-rated, therapeutically equivalent) | February 11, 2004 | 10MG;12.5MG, 20MG;12.5MG, 20MG;25MG, 5MG;6.25MG |
| SANDOZ INC | 076631 | AB (A-rated, therapeutically equivalent) | February 11, 2004 | 10MG;12.5MG, 20MG;12.5MG, 20MG;25MG, 5MG;6.25MG |
Lotensin HCT NDC codes
Questions
Is there a generic for Lotensin HCT?
Yes. The generic name for Lotensin HCT is benazepril and hydrochlorothiazide. 2 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 HCT?
The active ingredient in Lotensin HCT is benazepril and hydrochlorothiazide, 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.
More on Lotensin HCT and Benazepril and Hydrochlorothiazide
- What is Benazepril and Hydrochlorothiazide used for?FDA label uses
- Is Benazepril and Hydrochlorothiazide a controlled substance?Federal schedule
- ACE Inhibitors listFDA drug class
- Thiazide Diuretics listFDA drug class
- NDC 30698-452Lotensin HCT NDC record
- NDC 30698-453Lotensin HCT NDC record
- NDC 30698-454Lotensin HCT NDC record