Label: WARFARIN SODIUM tablet

  • NDC Code(s): 65841-052-01, 65841-052-10, 65841-053-01, 65841-053-10, view more
    65841-054-01, 65841-054-10, 65841-055-01, 65841-055-10, 65841-056-01, 65841-056-10, 65841-056-16, 65841-057-01, 65841-057-10, 65841-058-01, 65841-059-01, 65841-064-01, 65841-064-10
  • Packager: Cadila Healthcare Limited
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 14, 2020

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

  • MEDICATION GUIDE

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 65841-052-01 in bottle of 100 tablets

    Warfarin Sodium Tablets USP, 1 mg

    Rx only

    100 tablets

    Warfarin sodium tablets

    NDC 65841-053-01 in bottle of 100 tablets

    Warfarin Sodium Tablets USP, 2 mg

    Rx only

    100 tablets

    Warfarin Sodium tablet

    NDC 65841-064-01 in bottle of 100 tablets

    Warfarin Sodium Tablets USP, 2.5 mg

    Rx only

    100 tablets

    Warfarin Sodium tablets

    NDC 65841-054-01 in bottle of 100 tablets

    Warfarin Sodium Tablets USP, 3 mg

    Rx only

    100 tablets

    Warfarin Sodium tablets

    NDC 65841-055-01 in bottle of 100 tablets

    Warfarin Sodium Tablets USP, 4 mg

    Rx only

    100 tablets

    warfarin sodium tablet

    NDC 65841-056-01 in bottle of 100 tablets

    Warfarin Sodium Tablets USP, 5 mg

    Rx only

    100 tablets

    warfarin sodium tablet

    NDC 65841-057-01 in bottle of 100 tablets

    Warfarin Sodium Tablets USP, 6 mg

    Rx only

    100 tablets

    warfarin sodium tablet

    NDC 65841-058-01 in bottle of 100 tablets

    Warfarin Sodium Tablets USP, 7.5 mg

    Rx only

    100 tablets

    warfarin sodium tablet

    NDC 65841-059-01 in bottle of 100 tablets

    Warfarin Sodium Tablets USP, 10 mg

    Rx only

    100 tablets

    warfarin sodium tablet
  • INGREDIENTS AND APPEARANCE
    WARFARIN SODIUM 
    warfarin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-052
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM1 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C RED NO. 6 BARIUM LAKE (UNII: K4XZD9W99K)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorPINK (PINK) Score2 pieces
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code WAR;1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-052-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    2NDC:65841-052-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04066306/19/2006
    WARFARIN SODIUM 
    warfarin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-053
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM2 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorPURPLE (LAVENDER) Score2 pieces
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code WAR;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-053-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    2NDC:65841-053-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04066306/19/2006
    WARFARIN SODIUM 
    warfarin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-064
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM2.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorGREEN (GREEN) Score2 pieces
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code WAR;2;1;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-064-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    2NDC:65841-064-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04066306/19/2006
    WARFARIN SODIUM 
    warfarin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-054
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM3 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorBROWN (TAN) Score2 pieces
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code WAR;3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-054-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    2NDC:65841-054-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04066306/19/2006
    WARFARIN SODIUM 
    warfarin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-055
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM4 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorBLUE (BLUE) Score2 pieces
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code WAR;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-055-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    2NDC:65841-055-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04066306/19/2006
    WARFARIN SODIUM 
    warfarin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-056
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorORANGE (PEACH) Score2 pieces
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code WAR;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-056-1690 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    2NDC:65841-056-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    3NDC:65841-056-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04066306/19/2006
    WARFARIN SODIUM 
    warfarin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-057
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM6 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorGREEN (TEAL) Score2 pieces
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code WAR;6
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-057-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    2NDC:65841-057-101000 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04066306/19/2006
    WARFARIN SODIUM 
    warfarin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-058
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (YELLOW) Score2 pieces
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code WAR;7;1;2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-058-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04066306/19/2006
    WARFARIN SODIUM 
    warfarin sodium tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-059
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITE (WHITE TO OFF-WHITE) Score2 pieces
    ShapeOVAL (OVAL) Size11mm
    FlavorImprint Code WAR;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65841-059-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/19/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA04066306/19/2006
    Labeler - Cadila Healthcare Limited (918596198)
    Registrant - Cadila Healthcare Limited (918596198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cadila Healthcare Limited918596198ANALYSIS(65841-052, 65841-053, 65841-064, 65841-054, 65841-055, 65841-056, 65841-057, 65841-058, 65841-059) , MANUFACTURE(65841-052, 65841-053, 65841-064, 65841-054, 65841-055, 65841-056, 65841-057, 65841-058, 65841-059)