Irbesartan

Product NDC

0054-0250

11-digit product format

000540250

Labeler code

0054

Product ID

0054-0250_7d783004-ef17-4dcb-a3d9-4a965116ad4c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Irbesartan

Dosage form

TABLET

Route

ORAL

Labeler

West-Ward Pharmaceuticals Corp.

Application

ANDA090201

Marketing category

ANDA

Marketing start

2012-10-15

Marketing end

0000-00-00

Substance

IRBESARTAN

Active strength

75 mg/1

Pharmacologic classes

Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record