FDA Orange Book
Generic for Monoket
Monoket contains isosorbide mononitrate. 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 Monoket is isosorbide mononitrate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Monoket products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | 20MG | Marketed (Rx) | AB | 2 | AB |
NDA 020215, held by OMNIVIUM PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic isosorbide mononitrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GENUS LIFESCIENCES INC | 075037 | AB (A-rated, therapeutically equivalent) | October 30, 1998 | 10MG, 20MG |
| ANI PHARMACEUTICALS INC | 075147 | AB (A-rated, therapeutically equivalent) | March 27, 2026 | 10MG, 20MG |
Monoket NDC codes
Questions
Is there a generic for Monoket?
Yes. The generic name for Monoket is isosorbide mononitrate. 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 Monoket?
The active ingredient in Monoket is isosorbide mononitrate, 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.