FDA Orange Book
Generic for Mycelex
Mycelex contains clotrimazole. 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 Mycelex is clotrimazole. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
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Mycelex products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Discontinued | None | 3 | AB |
| solution, topical | 1% | Discontinued | None | 5 | AT |
| troche/lozenge, oral | 10MG | Discontinued | None | 3 | AB |
NDA 018183, 018181, 018713, held by BAYER HEALTHCARE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clotrimazole
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMA CANADA INC | 072640 | AB (A-rated, therapeutically equivalent) | August 31, 1993 | 1% |
| TEVA PHARMACEUTICALS USA INC | 073306 | AT (A-rated, therapeutically equivalent) | February 28, 1995 | 1% |
| SUN PHARMA CANADA INC | 074580 | AT (A-rated, therapeutically equivalent) | July 29, 1996 | 1% |
| HIKMA PHARMACEUTICALS USA INC | 076387 | AB (A-rated, therapeutically equivalent) | July 29, 2004 | 10MG |
| PADAGIS US LLC | 076763 | AB (A-rated, therapeutically equivalent) | October 28, 2005 | 10MG |
| FOUGERA PHARMACEUTICALS INC | 078338 | AB (A-rated, therapeutically equivalent) | September 2, 2008 | 1% |
| GLENMARK PHARMACEUTICALS INC USA | 090219 | AB (A-rated, therapeutically equivalent) | August 3, 2010 | 1% |
| NOVITIUM PHARMA LLC | 209815 | AT (A-rated, therapeutically equivalent) | February 14, 2019 | 1% |
| TP ANDA HOLDINGS LLC | 212281 | AT (A-rated, therapeutically equivalent) | July 25, 2019 | 1% |
| SCIEGEN PHARMACEUTICALS INC | 216569 | AT (A-rated, therapeutically equivalent) | October 16, 2023 | 1% |
| RISING PHARMA HOLDINGS INC | 215641 | AB (A-rated, therapeutically equivalent) | February 29, 2024 | 10MG |
Questions
Is there a generic for Mycelex?
Yes. The generic name for Mycelex is clotrimazole. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT.
What is the generic name for Mycelex?
The active ingredient in Mycelex is clotrimazole, 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.