Label: FENOFIBRATE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated May 20, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-010-52

    MFG: 0093-2060-98

    Fenofibrate 145mg

    30 Tablets

    Rx only

    Lot# NW89520001

    Exp Date: 06/2016

    Each tablet contains: 145mg of fenofibrate

    Dosage: See package insert

    Store at 77 degrees F. Protect from moisture.

    Store in a tight, light-resistant container (See USP) Keep out of reach of children.

    Mfg by: Fournier Laboratories Ireland Limited Anngrove, Carrigtwohill Co. Cork, Ireland

    Mfg for: Teva Pharmaceuticals USA Sellersville, PA 18960 Lot: 1007225

    Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

    Fenofibrate 51655-010

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    FENOFIBRATE 
    fenofibrate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-010(NDC:0093-2060)
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FENOFIBRATE (UNII: U202363UOS) (FENOFIBRATE - UNII:U202363UOS) FENOFIBRATE145 mg  in 30 
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize18mm
    FlavorImprint Code FO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-010-5230 in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA02165605/20/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-010)