Label: METFORMIN HYDROCHLORIDE tablet, extended release

  • NDC Code(s): 65841-027-01, 65841-027-05, 65841-039-01, 65841-039-05
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 5, 2022

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  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-027-05 in bottle of 500 tablets

    Metformin Hydrochloride Extended-release Tablets USP, 500 mg

    Rx only

    500 tablets

    500 mg

    NDC 65841-039-05 in bottle of 500 tablets

    Metformin Hydrochloride Extended-release Tablets USP, 750 mg

    Rx only

    500 tablets

    750 mg
  • INGREDIENTS AND APPEARANCE
    METFORMIN HYDROCHLORIDE 
    metformin hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-027
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code 63;Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-027-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    2NDC:65841-027-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07706009/28/2005
    METFORMIN HYDROCHLORIDE 
    metformin hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-039
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE750 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size19mm
    FlavorImprint Code Z;C;20
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-039-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    2NDC:65841-039-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07707809/28/2005
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited918596198ANALYSIS(65841-027, 65841-039) , MANUFACTURE(65841-027, 65841-039)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(65841-027, 65841-039) , MANUFACTURE(65841-027, 65841-039)
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