Active ingredient
Valganciclovir
27 finished FDA listings contain Valganciclovir as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- VALGANCICLOVIR, VALGANCICLOVIR HYDROCHLORIDE
- Dosage forms
- For Solution, Powder, For Solution, Tablet, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 20
- Strengths listed
- 450 mg/1 · 50 mg/ml
- Brand names in FDA listings
- Valcyte, Valganciclovir, Valganciclovir Hydrochloride, Valganciclovir Hydrochloride For Oral
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 275891
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 021304 | CHEPLAPHARM | 2001-03-29 | 1 |
| NDA 022257 | CHEPLAPHARM | 2009-08-28 | 1 |
| ANDA 203511 | DR REDDYS | 2014-11-04 | 2 |
| ANDA 200790 | STRIDES PHARMA INTL | 2014-11-04 | 3 |
| ANDA 205166 | HETERO LABS LTD V | 2016-03-18 | 3 |
| ANDA 204750 | AUROBINDO PHARMA LTD | 2016-03-31 | 2 |
| ANDA 205220 | ACTAVIS LABS FL INC | 2016-07-18 | 2 |
| ANDA 206876 | DR REDDYS | 2017-12-12 | 1 |
| ANDA 212234 | AJANTA PHARMA LTD | 2019-12-26 | 1 |
| ANDA 212890 | AJANTA PHARMA LTD | 2020-01-13 | 1 |
| ANDA 213306 | GRANULES | 2020-01-31 | 2 |
| ANDA 210169 | MSN | 2022-02-17 | 2 |
| ANDA 211475 | HETERO LABS LTD V | 2022-10-04 | 3 |
| ANDA 215124 | AUROBINDO PHARMA | 2022-11-17 | 1 |
| ANDA 216317 | APPCO | 2023-04-11 | 1 |
| ANDA 218838 | MICRO LABS | 2026-03-19 | 1 |
Official labeling on DailyMed
- VALGANCICLOVIR HYDROCHLORIDE FOR ORAL (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [ACTAVIS PHARMA, INC.] · version 26 · 2026-09-03
- VALGANCICLOVIR TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] · version 8 · 2026-06-26
- VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED] · version 3 · 2026-06-08
- VALGANCICLOVIR TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] · version 11 · 2026-06-03
- VALGANCICLOVIR POWDER, FOR SOLUTION [MICRO LABS LIMITED] · version 1 · 2026-06-02
- VALGANCICLOVIR TABLET, FILM COATED [MAJOR PHARMACEUTICALS] · version 6 · 2026-04-02
- VALGANCICLOVIR HYDROCHLORIDE TABLET [NORTHSTAR RX LLC] · version 1 · 2026-03-02
- VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE POWDER,) FOR SOLUTION [AUROBINDO PHARMA LIMITED] · version 3 · 2026-01-30
- VALGANCICLOVIR HYDROCHLORIDE (VALGANCICLOVIR) FOR SOLUTION [SOMERSET THERAPEUTICS, LLC] · version 4 · 2026-01-26
- VALGANCICLOVIR HYDROCHLORIDE TABLET [AUROBINDO PHARMA LIMITED] · version 12 · 2026-01-23
- VALGANCICLOVIR HYDROCHLORIDE FOR ORAL (VALGANCICLOVIR HYDROCHLORIDE) POWDER, FOR SOLUTION [AVKARE] · version 2 · 2026-01-21
- VALGANCICLOVIR (VALGANCICLOVIR HYDROCHLORIDE) TABLET, FILM COATED [AVKARE] · version 2 · 2026-01-21
Showing the 12 most recent of 26 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.