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Active ingredient

Losartan

206 finished FDA listings contain Losartan as their only active ingredient; 111 combination products also contain it.

FDA NDC Directory

Ingredient names as written by FDA
LOSARTAN POTASSIUM
Dosage forms
Suspension, Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
46
Strengths listed
10 mg/ml · 100 mg/1 · 25 mg/1 · 50 mg/1
Brand names in FDA listings
Arbli, Cozaar, Losartan Potassium, Losartan Potassium 100 Mg, Losartan Potassium 25 Mg, Losartan Potassium 50 Mg, Losartan Potassium Tablets, 100 Mg, Losartan Potassium Tablets, 25 Mg, Losartan Potassium Tablets, 50 Mg, Losortan Potassium

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 52175

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 020386ORGANON1995-04-143
ANDA 078243ZYDUS PHARMS USA INC2010-10-0632
ANDA 090083AUROBINDO PHARMA2010-10-0625
ANDA 078232LUPIN LTD2010-10-0613
ANDA 090382STRIDES PHARMA2010-10-0612
ANDA 090544AIPING PHARM INC2010-10-063
ANDA 090428ALEMBIC PHARMS LTD2010-10-066
ANDA 091497PRINSTON INC2011-06-0620
ANDA 202230MACLEODS PHARMS LTD2012-05-306
ANDA 201170JUBILANT CADISTA2012-09-1811
ANDA 091541MICRO LABS2012-09-241
ANDA 203835HETERO LABS LTD V2015-08-1255
ANDA 203030UNICHEM2015-10-146
ANDA 215959GRANULES2023-02-237
ANDA 217396MSN2023-08-145
NDA 218772SCIENTURE2025-03-131

Official labeling on DailyMed

Showing the 12 most recent of 137 labels.

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