FDA Orange Book
Generic for Monopril
Monopril contains fosinopril. 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 is fosinopril. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Monopril products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 5 | AB |
| tablet, oral | 20MG | Discontinued | None | 5 | AB |
| tablet, oral | 40MG | Discontinued | None | 5 | AB |
NDA 019915, held by BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic fosinopril
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 076139 | AB (A-rated, therapeutically equivalent) | November 25, 2003 | 10MG, 20MG, 40MG |
| CHARTWELL RX SCIENCES LLC | 076483 | AB (A-rated, therapeutically equivalent) | April 23, 2004 | 10MG, 20MG, 40MG |
| INVAGEN PHARMACEUTICALS INC | 077222 | AB (A-rated, therapeutically equivalent) | April 20, 2005 | 10MG, 20MG, 40MG |
| AUROBINDO PHARMA LIMITED | 091163 | AB (A-rated, therapeutically equivalent) | March 30, 2011 | 10MG, 20MG, 40MG |
| PRINSTON PHARMACEUTICAL INC | 205670 | AB (A-rated, therapeutically equivalent) | August 29, 2016 | 10MG, 20MG, 40MG |
Questions
Is there a generic for Monopril?
Yes. The generic name for Monopril is fosinopril. 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 Monopril?
The active ingredient in Monopril is fosinopril, 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.