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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.

ApplicationSponsorOriginal approvalListings
ANDA 076222HIKMA2003-07-161
NDA 022211BAUSCH AND LOMB2009-09-151
ANDA 090658FRESENIUS KABI USA2010-06-212
ANDA 204950PH HEALTH2016-12-061
ANDA 207645PHARMASCIENCE INC2017-12-082
ANDA 204204HAINAN POLY2018-11-082

Official labeling on DailyMed

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.