Label: ATORVASTATIN CALCIUM tablet, film coated

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

Drug Label Information

Updated March 11, 2014

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  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-920-30

    MFG: 60505-2579-8

    ATORVASTATIN CALCIUM 20 MG

    30 TABLETS

    RX ONLY

    Dosage: See package insert

    Store at 68 to 77 degrees F.

    Keep out of reach of children.

    Each film coated tablet contains Atorvastatin Calcium USP 20 MG

    Mfg by: Apotex Inc. Toronto Ontario Canada, M9L 1T9

    Repackaged by Northwind Pharmaceuticals Indianapolis, IN 46256

    Lot # NW30190001  EXP Date: 07/2015

    51655-920-30.jpg

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    ATORVASTATIN CALCIUM 
    atorvastatin calcium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-920(NDC:60505-2579)
    Route of AdministrationOral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATORVASTATIN CALCIUM (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN20 mg  in 30 
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize11mm
    FlavorImprint Code APO;ATV20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-920-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07647703/11/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-920)