Active ingredient
Penciclovir
5 finished FDA listings contain Penciclovir as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PENCICLOVIR
- Dosage forms
- Cream
- Routes
- Topical
- Manufacturers / labelers
- 4
- Strengths listed
- 10 mg/g
- Brand names in FDA listings
- Denavir
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 59839
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020629 | MYLAN | 1996-09-24 | 2 |
| ANDA 212710 | TEVA PHARMS USA | 2022-11-09 | 1 |
| ANDA 212368 | PADAGIS ISRAEL | 2024-09-27 | 1 |
| ANDA 214100 | AMNEAL | 2025-08-22 | 1 |
Official labeling on DailyMed
- PENCICLOVIR CREAM [AMNEAL PHARMACEUTICALS NY LLC] · version 3 · 2025-08-26
- DENAVIR (PENCICLOVIR) CREAM [MYLAN PHARMACEUTICALS INC.] · version 5 · 2025-01-30
- PENCICLOVIR CREAM [MYLAN PHARMACEUTICALS INC.] · version 2 · 2025-01-30
- PENCICLOVIR CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD] · version 2 · 2024-12-04
- PENCICLOVIR CREAM [TEVA PHARMACEUTICALS USA, INC.] · version 1 · 2022-11-16
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.