Label: COLCHICINE tablet

  • NDC Code(s): 70771-1396-1, 70771-1396-3, 70771-1396-5, 70771-1396-9, view more
    70771-1590-1, 70771-1590-3, 70771-1590-5, 70771-1590-9
  • Packager: Zydus Lifesciences Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 20, 2023

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  • SPL UNCLASSIFIED SECTION

  • SPL MEDGUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 70771-1396-3

    Colchicine tablets, USP 0.6 mg

    30 Tablets

    Rx only

    image

    NDC 70771-1590-3

    Colchicine tablets, USP 0.3 mg

    30 Tablets

    Rx only

    label
  • INGREDIENTS AND APPEARANCE
    COLCHICINE 
    colchicine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1396
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COLCHICEINE (UNII: HJ30158L57) (COLCHICEINE - UNII:HJ30158L57) COLCHICEINE0.6 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARMINIC ACID (UNII: CID8Z8N95N)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPURPLEScore2 pieces
    ShapeCAPSULESize8mm
    FlavorImprint Code 1351
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1396-31 in 1 CARTON06/12/2019
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70771-1396-91 in 1 CARTON06/12/2019
    290 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:70771-1396-11 in 1 CARTON06/12/2019
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:70771-1396-51 in 1 CARTON06/12/2019
    4500 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21151906/12/2019
    COLCHICINE 
    colchicine tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1590
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COLCHICEINE (UNII: HJ30158L57) (COLCHICEINE - UNII:HJ30158L57) COLCHICEINE0.3 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARMINIC ACID (UNII: CID8Z8N95N)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorPURPLEScore2 pieces
    ShapeROUND (Round) Size7mm
    FlavorImprint Code 1571
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70771-1590-31 in 1 CARTON05/10/2021
    130 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:70771-1590-91 in 1 CARTON05/10/2021
    290 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:70771-1590-11 in 1 CARTON05/10/2021
    3100 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:70771-1590-51 in 1 CARTON05/10/2021
    4500 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21151905/10/2021
    Labeler - Zydus Lifesciences Limited (918596198)
    Registrant - Zydus Lifesciences Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zydus Lifesciences Limited863362789ANALYSIS(70771-1396, 70771-1590) , MANUFACTURE(70771-1396, 70771-1590)
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