FDA Orange Book
Generic for Monopril-hct
Monopril-hct contains fosinopril 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 Monopril-hct is fosinopril and hydrochlorothiazide. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Monopril-hct and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Monopril-hct products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG;12.5MG | Discontinued | None | 3 | AB |
| tablet, oral | 20MG;12.5MG | Discontinued | None | 3 | AB |
NDA 020286, held by BRISTOL MYERS SQUIBB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fosinopril and hydrochlorothiazide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 076961 | AB (A-rated, therapeutically equivalent) | September 28, 2005 | 10MG;12.5MG, 20MG;12.5MG |
| AUROBINDO PHARMA LTD | 079245 | AB (A-rated, therapeutically equivalent) | July 9, 2009 | 10MG;12.5MG, 20MG;12.5MG |
| INVAGEN PHARMACEUTICALS INC | 090228 | AB (A-rated, therapeutically equivalent) | July 9, 2009 | 10MG;12.5MG, 20MG;12.5MG |
Questions
Is there a generic for Monopril-hct?
Yes. The generic name for Monopril-hct is fosinopril and hydrochlorothiazide. 3 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 Monopril-hct?
The active ingredient in Monopril-hct is fosinopril 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.