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 28, 2014

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  • PRINCIPAL DISPLAY PANEL

    NDC:51655-880-30

    MFG: 0591-3777-19

    Atorvastatin Calcium 80 mg

    30 tablets

    RX only

    Dosage: See package insert

    Store at 68 to 77 degrees F

    Keep out of the reach of children.

    Each tablet contains: Atorvastatin Calcium USP 80mg

    Mfg By: Pfizer Pharmaceuticals, Puerto Rico

    Repackaged by Northwind Pharmaceuticals Indianapolis, IN 46256

    Lot # NW30930001

    Exp Date: 09/2015

    Atorvastatin 80mg

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    ATORVASTATIN CALCIUM 
    atorvastatin calcium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-880(NDC:0591-3777)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATORVASTATIN CALCIUM (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN80 mg  in 30 
    Product Characteristics
    ColorwhiteScoreno score
    ShapecapsuleSize19mm
    FlavorImprint Code PD15880
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-880-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA02070204/28/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-880)