Label: FENOFIBRATE tablet

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

Drug Label Information

Updated May 7, 2014

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  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-009-52

    MFG: 0115-552-10

    Fenofibrate 160mg

    30 Tablets

    Rx Only

    Lot# NW89560001

    Exp Date: 09/2015

    Each tablet contains: 160mg of fenofibrate

    Dosage: See package insert

    Store at 60-77 degrees F. Store in a tight, light-resistant container (See USP)

    Keep out of the reach of children.

    Dist. By: Global Pharmaceuticals

    Division of IMPAX Laboratories, Inc

    Philadelphia, PA 19124 USA

    Product of Taiwan Lot: 10008621

    Repackaged by Northwind Pharmaceuticals, Indianapolis, IN 46256

    Fenofibrate 51655-009

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    FENOFIBRATE 
    fenofibrate tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-009(NDC:0115-5522)
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FENOFIBRATE (UNII: U202363UOS) (FENOFIBRATE - UNII:U202363UOS) FENOFIBRATE160 mg  in 30 
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code G;352
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-009-5230 in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07650905/07/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-009)