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 3, 2014

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  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-640-30

    MFG: 63304-829-05

    ATORVASTATIN CALCIUM 40 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 40 MG

    Mfg by:Ohm Laboratories North Brunswick, NJ 08902 USA

    Repackaged by Northwind Pharmaceuticals Indianapolis, IN 46256

    Lot # NW30900001 EXP Date: 03/2015

    Atorvastatin 40mg 51655-640-30

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    ATORVASTATIN CALCIUM 
    atorvastatin calcium tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-640(NDC:63304-829)
    Route of AdministrationOral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATORVASTATIN CALCIUM (UNII: 48A5M73Z4Q) (ATORVASTATIN - UNII:A0JWA85V8F) ATORVASTATIN40 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize10mm
    FlavorgrapeImprint Code RX829
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-640-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07647704/03/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-640)