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Active ingredient

Tenofovir Disoproxil

25 finished FDA listings contain Tenofovir Disoproxil as their only active ingredient; 65 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
TENOFOVIR DISOPROXIL FUMARATE
Dosage forms
Powder, Tablet, Tablet, Coated, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
16
Strengths listed
150 mg/1 · 200 mg/1 · 250 mg/1 · 300 mg/1 · 40 mg/g
Brand names in FDA listings
Tenofovir Disoproxil Fumarate, Viread

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 300195

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 021356GILEAD SCIENCES INC2001-10-264
NDA 022577GILEAD SCIENCES INC2012-01-181
ANDA 090636HETERO LABS LTD III2018-01-266
ANDA 203232MACLEODS PHARMS2018-01-262
ANDA 090742STRIDES PHARMA2018-01-262
ANDA 090647AUROBINDO PHARMA2018-01-264
ANDA 078800CIPLA2018-01-261
ANDA 209498QILU2018-03-024
ANDA 206481CHARTWELL2018-07-311

Official labeling on DailyMed

Showing the 12 most recent of 18 labels.

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