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Active ingredient

Lamivudine

29 finished FDA listings contain Lamivudine as their only active ingredient; 24 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
LAMIVUDINE
Dosage forms
Solution, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
15
Strengths listed
10 mg/ml · 100 mg/1 · 150 mg/1 · 300 mg/1
Brand names in FDA listings
Epivir, Lamivudine

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 68244

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 020596VIIV HLTHCARE1995-11-171
NDA 020564VIIV HLTHCARE1995-11-172
ANDA 091606APOTEX2011-12-026
ANDA 202941APOTEX2014-01-022
ANDA 203260HETERO LABS LTD V2014-01-021
ANDA 203277HETERO LABS LTD V2014-01-062
ANDA 203564CHARTWELL MOLECULAR2014-10-312
ANDA 205217LUPIN2014-12-181
ANDA 077464AUROBINDO PHARMA2016-11-212
ANDA 077695AUROBINDO PHARMA2016-11-212
ANDA 206974SOMERSET THERAPS LLC2016-11-212
ANDA 090457STRIDES PHARMA2018-04-193
ANDA 211306ANNORA2019-03-211
ANDA 090198MACLEODS PHARMS2019-05-012

Official labeling on DailyMed

Showing the 12 most recent of 19 labels.

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