Active ingredient
Famciclovir
26 finished FDA listings contain Famciclovir as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FAMCICLOVIR
- Dosage forms
- Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 9
- Strengths listed
- 125 mg/1 · 250 mg/1 · 500 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 68099
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 |
|---|---|---|---|
| ANDA 077487 | TEVA PHARMS | 2007-08-24 | 7 |
| ANDA 091114 | AUROBINDO PHARMA LTD | 2011-03-21 | 6 |
| ANDA 201022 | MACLEODS PHARMS LTD | 2012-01-12 | 5 |
| ANDA 202438 | HETERO LABS LTD V | 2014-09-10 | 8 |
Official labeling on DailyMed
- FAMCICLOVIR TABLET, FILM COATED [AVKARE] · version 1 · 2026-07-23
- FAMCICLOVIR TABLET, FILM COATED [AVKARE] · version 4 · 2026-01-16
- FAMCICLOVIR TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 1 · 2025-11-17
- FAMCICLOVIR TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] · version 20 · 2025-11-17
- FAMCICLOVIR TABLET, FILM COATED FAMCICLOVIR (FAMCICLOVIR ) TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] · version 14 · 2025-09-19
- FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [BRYANT RANCH PREPACK] · version 3 · 2025-03-27
- FAMCICLOVIR (FAMCICLOVIR) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] · version 7 · 2025-01-10
- FAMCICLOVIR TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] · version 4 · 2024-06-19
- FAMCICLOVIR TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 19 · 2024-06-18
- FAMCICLOVIR TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] · version 19 · 2023-08-07
- FAMCICLOVIR TABLET, FILM COATED [PROFICIENT RX LP] · version 2 · 2023-01-24
- FAMCICLOVIR TABLET, FILM COATED [PROFICIENT RX LP] · version 4 · 2022-06-27
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.