Active ingredient
Ganciclovir
9 finished FDA listings contain Ganciclovir as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GANCICLOVIR, GANCICLOVIR SODIUM
- Dosage forms
- Gel, Injection, Powder, Lyophilized, For Solution, Injection, Solution
- Routes
- Intravenous, Ophthalmic
- Manufacturers / labelers
- 7
- Strengths listed
- 1.5 mg/g · 50 mg/ml · 500 mg/10ml
- Brand names in FDA listings
- Ganciclovir, Zirgan
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4678
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 076222 | HIKMA | 2003-07-16 | 1 |
| NDA 022211 | BAUSCH AND LOMB | 2009-09-15 | 1 |
| ANDA 090658 | FRESENIUS KABI USA | 2010-06-21 | 2 |
| ANDA 204950 | PH HEALTH | 2016-12-06 | 1 |
| ANDA 207645 | PHARMASCIENCE INC | 2017-12-08 | 2 |
| ANDA 204204 | HAINAN POLY | 2018-11-08 | 2 |
Official labeling on DailyMed
- ZIRGAN (GANCICLOVIR) GEL [BAUSCH & LOMB INCORPORATED] · version 15 · 2026-05-21
- GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 8 · 2026-02-12
- GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] · version 6 · 2026-02-12
- GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 7 · 2025-02-10
- GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] · version 3 · 2025-01-24
- GANCICLOVIR SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] · version 2 · 2025-01-06
- GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, SOLUTION [PHARMASCIENCE INC.] · version 9 · 2022-12-23
- GANCICLOVIR (GANCICLOVIR SODIUM) INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 5 · 2022-12-01
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.