Label: ATORVASTATIN CALCIUM tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 25, 2014

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  • PRINCIPAL DISPLAY PANEL

    NDC 51655-610-30

    MFG: 63304-827-05

    ATORVASTATIN CALCIUM 10 MG

    30 TABLETS

    RX ONLY

    DOSAGE: SEE PACKAGE INSERT

    STORE AT 68 TO 77 DEGREES F

    KEEP OUT OF REACH OF CHILDREN

    Each tablet contains: Atorvastatin Calcium USP 10mg

    Mfg By: Ohm Laboratories, Northw Brunswick, NJ 08902 USA

    Repackaged by Northwind Pharmaceuticals Indianapolis, IN 46256

    Lot# NW30180001

    Exp Date: 05/2015

    Atorvastatin Calcium 10mg

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    ATORVASTATIN CALCIUM 
    atorvastatin calcium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-610(NDC:63304-827)
    Route of AdministrationOral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATORVASTATIN CALCIUM (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN10 mg  in 30 
    Product Characteristics
    ColorwhiteScoreno score
    ShapecapsuleSize10mm
    FlavorImprint Code RX12
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-610-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07647704/25/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-610)