Irbesartan

Product NDC

57297-410

11-digit product format

572970410

Labeler code

57297

Product ID

57297-410_d68faa18-807b-4fc0-808f-b00378a68a41

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Irbesartan

Dosage form

TABLET

Route

ORAL

Labeler

LUPIN LIMITED

Application

ANDA201531

Marketing category

ANDA

Marketing start

2012-10-23

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

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record