Avapro

Product NDC

35356-854

11-digit product format

353560854

Labeler code

35356

Product ID

35356-854_60be190c-9030-4a89-b143-3142de48e3b9

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

irbesartan

Dosage form

TABLET

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

NDA020757

Marketing category

NDA

Marketing start

2013-01-01

Marketing end

0000-00-00

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

2020-12-31

Current FDA listing

Historical FDA.report record