AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE

Product NDC

0781-5771

11-digit product format

007815771

Labeler code

0781

Product ID

0781-5771_07a597a4-a78e-4558-adda-335d316400a2

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

amlodipine valsartan and hydrochlorothiazide

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Sandoz Inc

Application

NDA022314

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2014-12-01

Marketing end

2021-05-31

Substance

AMLODIPINE BESYLATE; VALSARTAN; HYDROCHLOROTHIAZIDE

Active strength

5 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

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record