Irbesartan

Product NDC
72162-2355
11-digit product format
721622355
Labeler code
72162
Product ID
72162-2355_ab7543dc-4fcb-459d-93a2-619ea8389282
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irbesartan
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203071
Marketing category
ANDA
Marketing start
2016-06-13
Substance
IRBESARTAN
Active strength
150 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
J0E2756Z7NIRBESARTAN138402-11-6IRBESARTAN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2355-37216223550330 TABLET in 1 BOTTLE (72162-2355-3) 30 tablet2024-06-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
IrbesartanBryant Ranch Prepack2024-07-08HUMAN PRESCRIPTION DRUG LABEL101