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Active ingredient

Darunavir

32 finished FDA listings contain Darunavir as their only active ingredient; 5 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
DARUNAVIR, DARUNAVIR DIHYDRATE, DARUNAVIR ETHANOLATE, DARUNAVIR HYDRATE, DARUNAVIR PROPYLENE GLYCOLATE
Dosage forms
Suspension, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
14
Strengths listed
100 mg/ml · 150 mg/1 · 400 mg/1 · 600 mg/1 · 75 mg/1 · 800 mg/1
Brand names in FDA listings
Darunavir, Darunavir 600 And 800 Mg, Prezista

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 460132

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 021976JANSSEN PRODS2006-06-234
NDA 202895JANSSEN PRODS2011-12-161
ANDA 202073LUPIN2022-09-292
ANDA 202083HETERO LABS LTD III2023-09-142
ANDA 210677AUROBINDO PHARMA LTD2023-11-283
ANDA 206288CIPLA2023-11-287
ANDA 211578DR REDDYS2023-11-282
ANDA 215389MSN2023-11-283
ANDA 212493AMNEAL2023-12-082
ANDA 214085ZYDUS LIFESCIENCES2023-12-134
ANDA 216168ANNORA PHARMA2025-01-212

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.