Valsartan and Hydrochlorothiazide

Product NDC

35356-976

11-digit product format

353560976

Labeler code

35356

Product ID

35356-976_b12acecb-a486-44df-aee4-19a054c2502e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Valsartan and Hydrochlorothiazide

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA078946

Marketing category

ANDA

Marketing start

2013-03-21

Marketing end

0000-00-00

Substance

HYDROCHLOROTHIAZIDE; VALSARTAN

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

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record