Irbesartan and Hydrochlorothiazide

Product NDC

64980-382

11-digit product format

649800382

Labeler code

64980

Product ID

64980-382_6f3abf6a-057c-46cb-9b5d-b8b54171c77d

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Irbesartan and Hydrochlorothiazide

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Rising Pharmaceuticals, Inc.

Application

ANDA203630

Marketing category

ANDA

Marketing start

2017-11-07

Marketing end

0000-00-00

Substance

IRBESARTAN; HYDROCHLOROTHIAZIDE

Active strength

150 mg/1; mg/1

Pharmacologic classes

Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record