Label: METFORMIN HCL- metformin hcl tablet, film coated

  • NDC Code(s): 49483-620-01, 49483-620-10, 49483-620-50, 49483-620-81, view more
    49483-621-01, 49483-621-10, 49483-621-50, 49483-621-81, 49483-622-01, 49483-622-10, 49483-622-50, 49483-622-81
  • Packager: TIME CAP LABORATORIES, INC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 1, 2018

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

  • HOW SUPPLIED

    METFORMIN HYDROCHLORIDE TABLETS, USP 500 MG ARE WHITE TO OFF-WHITE COLORED, FILM COATED, ROUND SHAPED WITH BEVELED EDGES ON BOTH SIDES AND DEBOSSED WITH "134" ON ONE SIDE AND PLAIN ON THE OTHER SIDE. BOTTLES OF 100 AND 500.

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  • HOW SUPPLIED

    METFORMIN HYDROCHLORIDE TABLETS, USP 850 MG ARE WHITE TO OFF-WHITE COLORED, FILM COATED, ROUND SHAPED WITH BEVELED EDGES ON BOTH SIDES AND DEBOSSED WITH "131" ON ONE SIDE AND PLAIN ON THE OTHER SIDE.  BOTTLES OF 100 AND 500.

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  • HOW SUPPLIED

    METFORMIN HYDROCHLORIDE TABLETS, USP 1000 MG ARE WHITE TO OFF-WHITE COLORED, FILM COATED, OVAL SHAPED WITH BEVELED EDGES ON BOTH SIDES AND DEBOSSED WITH "132" ON ONE SIDE AND PLAIN ON THE OTHER SIDE. BOTTLES OF 100 AND 500.

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  • 100 ct 620R 1000 MG
  • 100 CT 621R
  • 100 CT 622R
  • INGREDIENTS AND APPEARANCE
    METFORMIN HCL 
    metformin hcl tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-620
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 1000 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white (WHITE TO OFF-WHITE) Score 2 pieces
    Shape OVAL Size 19mm
    Flavor Imprint Code 132
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-620-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2016
    2 NDC:49483-620-81 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2017
    3 NDC:49483-620-50 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2016
    4 NDC:49483-620-10 1000 in 1 PACKAGE; Type 0: Not a Combination Product 06/05/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090888 11/14/2016
    METFORMIN HCL 
    metformin hcl tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-621
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 850 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white (WHITE TO OFF-WHITE) Score no score
    Shape ROUND Size 13mm
    Flavor Imprint Code 131
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-621-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2016
    2 NDC:49483-621-81 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2017
    3 NDC:49483-621-50 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2016
    4 NDC:49483-621-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090888 11/14/2016
    METFORMIN HCL 
    metformin hcl tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49483-622
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METFORMIN HYDROCHLORIDE (UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N) METFORMIN HYDROCHLORIDE 500 mg
    Inactive Ingredients
    Ingredient Name Strength
    POVIDONE (UNII: FZ989GH94E)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color white (WHITE TO OFF-WHITE) Score no score
    Shape ROUND Size 12mm
    Flavor Imprint Code 134
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49483-622-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2016
    2 NDC:49483-622-81 180 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2017
    3 NDC:49483-622-50 500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/16/2016
    4 NDC:49483-622-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/05/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090888 11/14/2016
    Labeler - TIME CAP LABORATORIES, INC (037052099)
    Registrant - TIME CAP LABORATORIES, INC (037052099)
    Establishment
    Name Address ID/FEI Business Operations
    MARKSANS PHARMA LIMITED 925822975 manufacture(49483-620, 49483-621, 49483-622)
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