WARFARIN SODIUM- warfarin sodium tablet 
Cadila Healthcare Limited

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WARFARIN SODIUM TABLETS, USP

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
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)

Revised: 9/2020
Document Id: b9846c53-80c7-4264-a78f-87c3b18edfc7
Set id: 3fb2aa58-3a40-4255-a261-e2db5b9a5dde
Version: 6
Effective Time: 20200914
 
Cadila Healthcare Limited