Irbesartan and Hydrochlorothiazide

Product NDC

57297-414

11-digit product format

572970414

Labeler code

57297

Product ID

57297-414_ac69bbca-81f4-4896-bb7e-df0a4428fe42

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Irbesartan and Hydrochlorothiazide

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

LUPIN LIMITED

Application

ANDA201524

Marketing category

ANDA

Marketing start

2013-04-04

Marketing end

0000-00-00

Substance

HYDROCHLOROTHIAZIDE; IRBESARTAN

Active strength

13 mg/1; mg/1

Pharmacologic classes

Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],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