Label: DIGOXIN tablet

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

Drug Label Information

Updated May 16, 2014

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  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-001-52

    MFG: 0527-1324-10

    Digoxin 0.125 MG

    30 Tablets

    Rx Only

    Lot# NW41850001

    EXP Date: 12/2015

    Each tablet contains Digoxin, USP...0.125mg

    Dosage: See package insert

    Store at 59 to 77 degrees F in a dry place and protect from light.

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

    Mfg by: Jerome Stevens Pharmaceuticals, Inc Bohemia, NY 11716

    Mfg for: Lannett Co. Inc, Philadelphia, PA 19136 Lot # 038813

    Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

    Digoxin 0.125 mg 51655-001

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    DIGOXIN 
    digoxin tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-001(NDC:0527-1324)
    Route of Administrationoral
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIGOXIN (UNII: 73K4184T59) (DIGOXIN - UNII:73K4184T59) DIGOXIN0.125 mg  in 30 
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code JSP544
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-001-5230 in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07626805/16/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-001)