FDA Orange Book
Generic for Denavir
Denavir contains penciclovir. 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 Denavir is penciclovir. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Denavir products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Marketed (Rx) | AB | 3 | AB |
NDA 020629, held by MYLAN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic penciclovir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA INC | 212710 | AB (A-rated, therapeutically equivalent) | November 9, 2022 | 1% |
| PADAGIS ISRAEL PHARMACEUTICALS LTD | 212368 | AB (A-rated, therapeutically equivalent) | September 27, 2024 | 1% |
| AMNEAL PHARMACEUTICALS LLC | 214100 | AB (A-rated, therapeutically equivalent) | August 22, 2025 | 1% |
Denavir NDC codes
Questions
Is there a generic for Denavir?
Yes. The generic name for Denavir is penciclovir. 3 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 Denavir?
The active ingredient in Denavir is penciclovir, 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.