AMLODIPINE AND VALSARTAN

Product NDC

0781-5639

11-digit product format

007815639

Labeler code

0781

Product ID

0781-5639_054546f4-f406-4a5c-91ba-d981071cf38b

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

amlodipine besylate and valsartan

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Sandoz Inc

Application

NDA021990

Marketing category

NDA AUTHORIZED GENERIC

Marketing start

2015-03-30

Marketing end

2022-09-30

Substance

AMLODIPINE BESYLATE; VALSARTAN

Active strength

5 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]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record