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Active ingredient

Entecavir

31 finished FDA listings contain Entecavir as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
ENTECAVIR, ENTECAVIR ANHYDROUS
Dosage forms
Solution, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
17
Strengths listed
.05 mg/ml · .5 mg/1 · 1 mg/1
Brand names in FDA listings
Baraclude, Entecavir

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 306266

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 021797BRISTOL MYERS SQUIBB2005-03-292
NDA 021798BRISTOL MYERS SQUIBB2005-03-291
ANDA 205740HETERO LABS LTD V2015-08-212
ANDA 206217AUROBINDO PHARMA2015-08-263
ANDA 206652AMNEAL PHARMS2015-11-123
ANDA 206872CIPLA2016-12-064
ANDA 206745ZYDUS PHARMS2017-06-234
ANDA 208782PRINSTON INC2017-10-102
ANDA 212126BRIGHTGENE2019-09-252
ANDA 212201YAOPHARMA CO LTD2019-11-042
ANDA 208195YUNG SHIN PHARM2021-11-102
ANDA 216857CONBA USA2024-12-234

Official labeling on DailyMed

Showing the 12 most recent of 16 labels.

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