Label: GLIPIZIDE AND METFORMIN HYDROCHLORIDE tablet, film coated
GLIPIZIDE AND METFORMIN HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 65841-659-01, 65841-659-10, 65841-659-16, 65841-659-30, view more
    65841-659-77, 65841-660-01, 65841-660-10, 65841-660-16, 65841-660-30, 65841-660-77, 65841-661-01, 65841-661-10, 65841-661-16, 65841-661-30, 65841-661-77
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 28, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-659-01 in bottle of 100 tablets

    Glipizide and Metformin Hydrochloride Tablets USP, 2.5 mg/250 mg

    Rx only

    100 tablets

    Glipizide and Metformin HCL Tablets

    NDC 65841-660-01 in bottle of 100 tablets

    Glipizide and Metformin Hydrochloride Tablets USP, 2.5 mg/500 mg

    Rx only

    100 tablets

    Glipizide and metformin HCL Tablets

    NDC 65841-661-01 in bottle of 100 tablets

    Glipizide and Metformin Hydrochloride Tablets USP, 5 mg/500 mg

    Rx only

    100 tablets

    Glipizide and metformin HCL Tablets
  • INGREDIENTS AND APPEARANCE
    GLIPIZIDE AND METFORMIN HYDROCHLORIDE 
    glipizide and metformin hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-659
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE2.5 mg
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Product Characteristics
    ColorPINK (PINK) Scoreno score
    ShapeCAPSULE (CAPSULE) Size11mm
    FlavorImprint Code ZE68
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-659-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
    2NDC:65841-659-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
    3NDC:65841-659-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
    4NDC:65841-659-7710 in 1 CARTON05/05/2016
    4NDC:65841-659-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07890505/05/2016
    GLIPIZIDE AND METFORMIN HYDROCHLORIDE 
    glipizide and metformin hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-660
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE2.5 mg
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorWHITE (WHITE) Scoreno score
    ShapeCAPSULE (CAPSULE) Size15mm
    FlavorImprint Code ZE67
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-660-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
    2NDC:65841-660-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
    3NDC:65841-660-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
    4NDC:65841-660-7710 in 1 CARTON05/05/2016
    4NDC:65841-660-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07890505/05/2016
    GLIPIZIDE AND METFORMIN HYDROCHLORIDE 
    glipizide and metformin hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-661
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C) GLIPIZIDE5 mg
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPINK (PINK) Scoreno score
    ShapeCAPSULE (CAPSULE) Size15mm
    FlavorImprint Code ZE66
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-661-1690 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
    2NDC:65841-661-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
    3NDC:65841-661-101000 in 1 BOTTLE; Type 0: Not a Combination Product05/05/2016
    4NDC:65841-661-7710 in 1 CARTON05/05/2016
    4NDC:65841-661-3010 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07890505/05/2016
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-659, 65841-660, 65841-661) , MANUFACTURE(65841-659, 65841-660, 65841-661)