VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS]

VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET [NORTHWIND PHARMACEUTICALS]
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NDC 51655-951-52
Set ID 13fb8c27-0a47-4cfa-a217-29cd6d14c4b8
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Northwind Pharmaceuticals
Generic Name
Product Class Angiotensin 2 Receptor Blocker
Product Number
Application Number ANDA202519
  • 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

    Valsartan 51655-951

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    VALSARTAN AND HYDROCHLOROTHIAZIDE 
    valsartan and hydrochlorothiazide tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-951(NDC:65862-551)
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I) VALSARTAN320 mg  in 30 
    HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH) HYDROCHLOROTHIAZIDE25 mg  in 30 
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize22mm
    FlavorImprint Code I65
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-951-5230 in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20251905/06/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-951)

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