Label: METFORMIN HYDROCHLORIDE tablet

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

Drug Label Information

Updated June 6, 2014

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  • PRINCIPAL DISPLAY PANEL

    NDC: 51655-560-25

    MFG: 23155-103-10

    Metformin HCL 850MG

    60 Tablets

    Rx only

    Lot#:

    Exp. Date:

    Each tablet contains: Metformin hydrochloride, USP...850mg

    Dosage: See package insert

    Store between 68-77 degrees F.  Protect form moisture.

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

    Mfg by: Granules India ltd., Ranga Reddy Dist. India 500-043, AP

    Mfg. for: Heritage Pharmaceuticals Inc. Edison, NJ 08837 Lot#

    Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

    Metformin HCL 51655-560

  • WARNINGS AND PRECAUTIONS

  • INGREDIENTS AND APPEARANCE
    METFORMIN HYDROCHLORIDE 
    metformin hydrochloride tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51655-560(NDC:23155-103)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE850 mg
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize13mm
    FlavorImprint Code H103
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51655-560-2560 in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09056404/08/2014
    Labeler - Northwind Pharmaceuticals (036986393)
    Registrant - Northwind Pharmaceuticals (036986393)
    Establishment
    NameAddressID/FEIBusiness Operations
    Northwind Pharmaceuticals036986393repack(51655-560)