VALSARTAN HCTZ TABLET [NORTHWIND PHARMACEUTICALS]

VALSARTAN HCTZ TABLET [NORTHWIND PHARMACEUTICALS]
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NDC 51655-950-52
Set ID 2a29600b-500c-403e-b407-023da4381fbb
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Northwind Pharmaceuticals
Generic Name
Product Class Angiotensin 2 Receptor Blocker
Product Number
Application Number ANDA091519
  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-950-52

    MFG: 0591-2316-10

    Valsartan HCTZ

    160/12.5MG

    30 tablets

    Rx only

    Lot# NW23790001

    Exp Date: 02/2015

    Each tablet contains: 160mg of Valsartan and 12.5mg of hydrochlorothiazide, USP

    Dosage: See package insert

    Store at 68 to 77 degrees F.

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

    Keep out of reach of children.

    Mfg by: Arrow Pharm (Malta) Ltd. Birzebbugia, BBG06, Malta

    Distr. by: Watson Pharma, Inc Parsippany, NJ 07054 USA Lot# 3019329

    Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

    Valsartan 51655-950

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    VALSARTAN HCTZ 
    valsartan hctz tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-950(NDC:0591-2316)
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN160 mg  in 30 
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE12.5 mg  in 30 
    Product Characteristics
    ColorredScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code VH2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-950-5230 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09151905/06/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-950)

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