VALSARTAN AND HYDROCHLOROTHIAZIDE tablet

Valsartan and Hydrochlorothiazide by

Drug Labeling and Warnings

Valsartan and Hydrochlorothiazide by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NDC: 51655-951-52

MFG: 65862-551-90

Valsartan HCTZ

320mg/25mg

30 Tablets

Rx only

Lot# NW48300001

Exp Date: 12/2015

Each tablet contains: 320mg of Valsartan and 25mg of Hydrochlorothiazide, USP

Dosage: See package insert

Store at 68 to 77 degreesF.

Store in a tight, light-resistant container (See USP)

Keep out of reach of children.

MFG by: Aurobindo Pharma Limited, Unit-VII (SEZ) Mahaboob Nagar (Dt) AP-509302, India

MFG for: Aurobindo Pharma USA, Inc, 2400 Route 130 North, Dayton, NJ 08810 LotL HTSB14004-A

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

WARNINGS AND PRECAUTIONS

INGREDIENTS AND APPEARANCE

VALSARTAN AND HYDROCHLOROTHIAZIDE 
valsartan and hydrochlorothiazide tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51655-951(NDC:65862-551)
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)	VALSARTAN	320 mg  in 30
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)	HYDROCHLOROTHIAZIDE	25 mg  in 30

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	I65
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51655-951-52	30 in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA202519	05/06/2014

Labeler - Northwind Pharmaceuticals (036986393)

Registrant - Northwind Pharmaceuticals (036986393)

Establishment
Name	Address	ID/FEI	Business Operations
Northwind Pharmaceuticals		036986393	repack(51655-951)