FDA Orange Book
Generic for Monistat
Monistat contains miconazole nitrate. 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 Monistat is miconazole nitrate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Monistat products the Orange Book lists.
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Monistat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10MG/ML | Discontinued | None | 0 | None |
| suppository, vaginal | 200MG | Marketed (Rx) | AB | 1 | AB |
| tampon, vaginal | 100MG | Discontinued | None | 0 | None |
NDA 018040, 018888, 018592, held by MEDTECH PRODUCTS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic miconazole nitrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS PHARMA INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 073508 | AB (A-rated, therapeutically equivalent) | November 19, 1993 | 200MG |
Questions
Is there a generic for Monistat?
Yes. The generic name for Monistat is miconazole nitrate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 3 Monistat products the Orange Book lists.
What is the generic name for Monistat?
The active ingredient in Monistat is miconazole nitrate, 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.