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Active ingredient

Valacyclovir

113 finished FDA listings contain Valacyclovir as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE MONOHYDRATE
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
41
Strengths listed
1 g/1 · 1000 mg/1 · 500 mg/1
Brand names in FDA listings
Valacyclovir, Valacyclovir Hydrochloride, Valtrex

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 73645

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
NDA 020487GLAXOSMITHKLINE1995-06-233
ANDA 076588SUN PHARM INDS LTD2007-01-315
ANDA 079012RISING2010-05-242
ANDA 078518MYLAN PHARMS INC2010-05-2410
ANDA 090682AUROBINDO PHARMA2010-05-2442
ANDA 201506JUBILANT GENERICS2012-04-034
ANDA 203047HETERO LABS LTD V2015-04-0822
ANDA 209553YILING2020-03-1825

Official labeling on DailyMed

Showing the 12 most recent of 93 labels.

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