FDA Orange Book
Generic for Femstat
Femstat contains butoconazole 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 Femstat is butoconazole nitrate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 2 of the 3 Femstat products the Orange Book lists.
Run it in Rivvi
Map Femstat 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.
Femstat products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, vaginal | 2% | Discontinued | None | 1 | None |
| cream, vaginal | 2% | Discontinued | None | 1 | None |
| suppository, vaginal | 100MG | Discontinued | None | 0 | None |
NDA 019215, 020421, 019359, held by ROCHE PALO ALTO LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic butoconazole nitrate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 200923 | None (No TE code listed) | May 18, 2012 | 2%, 2% |
Questions
Is there a generic for Femstat?
Yes. The generic name for Femstat is butoconazole nitrate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Generics match 2 of the 3 Femstat products the Orange Book lists.
What is the generic name for Femstat?
The active ingredient in Femstat is butoconazole 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.