Label: METFORMIN HYDROCHLORIDE tablet, film coated

  • NDC Code(s): 65841-028-01, 65841-028-05, 65841-028-10, 65841-028-16, view more
    65841-028-30, 65841-028-77, 65841-029-01, 65841-029-05, 65841-029-10, 65841-029-16, 65841-029-30, 65841-029-77, 65841-030-01, 65841-030-05, 65841-030-10, 65841-030-16, 65841-030-30, 65841-030-77, 65841-809-01, 65841-809-05, 65841-809-10, 65841-809-16, 65841-809-30, 65841-809-77, 65841-810-01, 65841-810-05, 65841-810-10, 65841-810-16, 65841-810-30, 65841-810-77, 65841-811-01, 65841-811-05, 65841-811-10, 65841-811-16, 65841-811-30, 65841-811-77
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 1, 2020

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

  • SPL UNCLASSIFIED SECTION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-028-01 in bottle of 100 tablets

    Metformin Hydrochloride Tablets USP, 500 mg

    Rx only

    100 tablets

    Image

    NDC 65841-809-01 in bottle of 100 tablets

    Metformin Hydrochloride Tablets USP, 500 mg

    Rx only

    100 tablets

    Image

    NDC 65841-029-01 in bottle of 100 tablets

    Metformin Hydrochloride Tablets USP, 850 mg

    Rx only

    100 tablets

    Image

    NDC 65841-810-01 in bottle of 100 tablets

    Metformin Hydrochloride Tablets USP, 850 mg

    Rx only

    100 tablets

    Image

    NDC 65841-030-01 in bottle of 100 tablets

    Metformin Hydrochloride Tablets USP, 1000 mg

    Rx only

    100 tablets

    Image

    NDC 65841-811-01 in bottle of 100 tablets

    Metformin Hydrochloride Tablets USP, 1000 mg

    Rx only

    100 tablets

    Image
  • INGREDIENTS AND APPEARANCE
    METFORMIN HYDROCHLORIDE 
    metformin hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-028
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size13mm
    FlavorImprint Code 70;Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-028-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    2NDC:65841-028-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    3NDC:65841-028-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    4NDC:65841-028-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    5NDC:65841-028-77100 in 1 CARTON09/28/2005
    5NDC:65841-028-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07706409/28/2005
    METFORMIN HYDROCHLORIDE 
    metformin hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-029
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE850 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOVAL (OVAL) Size19mm
    FlavorImprint Code 69;Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-029-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    2NDC:65841-029-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    3NDC:65841-029-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    4NDC:65841-029-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    5NDC:65841-029-77100 in 1 CARTON09/28/2005
    5NDC:65841-029-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07706409/28/2005
    METFORMIN HYDROCHLORIDE 
    metformin hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-030
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size19mm
    FlavorImprint Code Z;71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-030-1690 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    2NDC:65841-030-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    3NDC:65841-030-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    4NDC:65841-030-101000 in 1 BOTTLE; Type 0: Not a Combination Product09/28/2005
    5NDC:65841-030-77100 in 1 CARTON09/28/2005
    5NDC:65841-030-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07706409/28/2005
    METFORMIN HYDROCHLORIDE 
    metformin hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-809
    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
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeROUND (ROUND) Size13mm
    FlavorImprint Code 70;Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-809-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    2NDC:65841-809-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    3NDC:65841-809-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    4NDC:65841-809-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    5NDC:65841-809-77100 in 1 CARTON12/09/2014
    5NDC:65841-809-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20368612/09/2014
    METFORMIN HYDROCHLORIDE 
    metformin hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-810
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE850 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
    ShapeOVAL (OVAL) Size19mm
    FlavorImprint Code 69;Z
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-810-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    2NDC:65841-810-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    3NDC:65841-810-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    4NDC:65841-810-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    5NDC:65841-810-77100 in 1 CARTON12/09/2014
    5NDC:65841-810-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20368612/09/2014
    METFORMIN HYDROCHLORIDE 
    metformin hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-811
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size19mm
    FlavorImprint Code Z;71
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-811-1690 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    2NDC:65841-811-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    3NDC:65841-811-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    4NDC:65841-811-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/09/2014
    5NDC:65841-811-77100 in 1 CARTON12/09/2014
    5NDC:65841-811-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20368612/09/2014
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811) , MANUFACTURE(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited863362789ANALYSIS(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811) , MANUFACTURE(65841-028, 65841-029, 65841-030, 65841-809, 65841-810, 65841-811)