FDA Orange Book
Generic for Penlac
Penlac contains ciclopirox. 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 Penlac is ciclopirox. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
Run it in Rivvi
Map Penlac 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.
Penlac products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, topical | 8% | Discontinued | None | 5 | AT |
NDA 021022, held by VALEANT INTERNATIONAL BERMUDA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ciclopirox
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACELLA PHARMACEUTICALS LLC | 078172 | AT (A-rated, therapeutically equivalent) | September 18, 2007 | 8% |
| CHARTWELL RX SCIENCES LLC | 078046 | AT (A-rated, therapeutically equivalent) | September 18, 2007 | 8% |
| ENCUBE ETHICALS PRIVATE LTD | 077687 | AT (A-rated, therapeutically equivalent) | September 18, 2007 | 8% |
| PADAGIS US LLC | 077623 | AT (A-rated, therapeutically equivalent) | September 18, 2007 | 8% |
| RISING PHARMA HOLDINGS INC | 078124 | AT (A-rated, therapeutically equivalent) | September 18, 2007 | 8% |
Questions
Is there a generic for Penlac?
Yes. The generic name for Penlac is ciclopirox. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Penlac?
The active ingredient in Penlac is ciclopirox, 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.