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Active ingredient

Irbesartan

83 finished FDA listings contain Irbesartan as their only active ingredient; 31 combination products also contain it.

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FDA NDC Directory

Ingredient names as written by FDA
IRBESARTAN
Dosage forms
Tablet, Tablet, Film Coated
Routes
Oral
Manufacturers / labelers
24
Strengths listed
150 mg/1 · 300 mg/1 · 75 mg/1
Brand names in FDA listings
Avapro

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 83818

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 020757SANOFI AVENTIS US1997-09-302
ANDA 203081AUROBINDO PHARMA LTD2012-09-273
ANDA 203071PRINSTON INC2012-09-2712
ANDA 202910HETERO LABS LTD V2012-09-2720
ANDA 202254MACLEODS PHARMS LTD2012-10-0311
ANDA 201531LUPIN LTD2012-10-152
ANDA 091236ALEMBIC PHARMS LTD2012-10-156
ANDA 077205CHARTWELL MOLECULAR2012-11-143
ANDA 203534JUBILANT GENERICS2015-02-236
ANDA 203020UNICHEM2015-12-073
ANDA 204774SCIEGEN PHARMS2015-12-076
ANDA 206194HISUN PHARM HANGZHOU2016-06-143
ANDA 204740AMNEAL PHARMS2018-04-173
ANDA 219539MSN2025-11-043

Official labeling on DailyMed

Showing the 12 most recent of 43 labels.

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