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Active ingredient

Acyclovir

204 finished FDA listings contain Acyclovir as their only active ingredient; 1 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
ACYCLOVIR, ACYCLOVIR SODIUM
Dosage forms
Capsule, Cream, Injection, Powder, Lyophilized, For Solution, Injection, Solution, Ointment, Suspension, Tablet
Routes
Cutaneous, Intravenous, Ophthalmic, Oral, Topical
Manufacturers / labelers
71
Strengths listed
1 g/1 · 1000 mg/20ml · 200 mg/1 · 200 mg/5ml · 30 mg/g · 400 mg/1 · 50 mg/g · 50 mg/ml · 500 mg/1 · 500 mg/10ml · 800 mg/1
Brand names in FDA listings
Acyclovir Suspension, Avaclyr, Zovirax

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 281

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 018604BAUSCH1982-03-292
ANDA 074738ACTAVIS MID ATLANTIC1997-04-283
ANDA 074891HERITAGE1997-10-3110
ANDA 074889HERITAGE1997-10-313
ANDA 074930FRESENIUS KABI USA1998-05-132
ANDA 075211AUROBINDO PHARMA USA1998-09-282
ANDA 075090REGCON HOLDINGS1999-01-266
ANDA 075382CARLSBAD1999-04-3016
NDA 021478BAUSCH2002-12-302
ANDA 075677APOTEX2005-09-284
ANDA 077309APOTEX2005-09-2912
ANDA 202459PHARMOBEDIENT2013-04-031
ANDA 203701EUGIA PHARMA2013-10-115
ANDA 203834HETERO LABS LTD V2013-10-2923
ANDA 202168CADILA PHARMS LTD2013-11-154
ANDA 201445CADILA PHARMS LTD2014-03-062
ANDA 204605AMNEAL PHARMS2014-06-181
ANDA 204314ZYDUS PHARMS2014-08-1912
ANDA 205771HIKMA2016-02-292
ANDA 204313CADILA2016-03-259
ANDA 205510GLENMARK SPECLT2017-07-314
ANDA 206261CARLSBAD2017-08-166
ANDA 210401YILING2018-03-0718
ANDA 206535ZYDUS PHARMS2018-08-314
ANDA 209971TORRENT2019-01-112
ANDA 208702PADAGIS ISRAEL2019-02-042
ANDA 205974ZYDUS LIFESCIENCES2019-03-155
NDA 202408FERA PHARMS LLC2019-03-291
ANDA 209366ADAPTIS2019-10-0714
ANDA 201501XIROMED2020-01-294
ANDA 212718CHARTWELL RX2020-04-232
ANDA 212252NOVITIUM PHARMA2020-07-101
ANDA 212173YILING2020-09-143
ANDA 212444MACLEODS PHARMS2021-05-191
ANDA 212202PRINSTON INC2021-11-151
ANDA 215724RUBICON RESEARCH2022-08-181
ANDA 206770ZYDUS LIFESCIENCES2023-02-282
ANDA 217393MSN2023-03-092
ANDA 212361ALEMBIC2023-11-211
ANDA 215404FRESENIUS KABI USA2024-06-252

Showing 40 of 47 applications.

Official labeling on DailyMed

Showing the 12 most recent of 177 labels.

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