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Active ingredient

Abacavir

15 finished FDA listings contain Abacavir as their only active ingredient; 8 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
ABACAVIR, ABACAVIR SULFATE
Dosage forms
Solution, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
13
Strengths listed
20 mg/ml · 300 mg/1
Brand names in FDA listings
Abacavir, Ziagen

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 190521

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 020978VIIV HLTHCARE1998-12-171
ANDA 091294MYLAN PHARMS INC2012-06-183
ANDA 077844AUROBINDO PHARMA LTD2012-12-173
ANDA 091560HETERO LABS LTD III2013-09-134
ANDA 201107HETERO LABS LTD III2016-09-261
ANDA 078119CIPLA2017-11-211
ANDA 077950AUROBINDO PHARMA LTD2018-03-142

Official labeling on DailyMed

Showing the 12 most recent of 15 labels.

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