Amlodipine, Valsartan and Hydrochlorothiazide

Product NDC

57297-774

11-digit product format

572970774

Labeler code

57297

Product ID

57297-774_b17081c0-a99a-48eb-be9f-494591f7466c

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Amlodipine, Valsartan and Hydrochlorothiazide

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

LUPIN LIMITED

Application

ANDA200797

Marketing category

ANDA

Marketing start

2015-06-03

Marketing end

0000-00-00

Substance

AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE

Active strength

10 mg/1; mg/1; mg/1

Pharmacologic classes

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

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record