SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-052-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 1 mg

Rx only

100 tablets

NDC 65841-053-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 2 mg

Rx only

100 tablets

NDC 65841-064-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 2.5 mg

Rx only

100 tablets

NDC 65841-054-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 3 mg

Rx only

100 tablets

NDC 65841-055-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 4 mg

Rx only

100 tablets

NDC 65841-056-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 5 mg

Rx only

100 tablets

NDC 65841-057-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 6 mg

Rx only

100 tablets

NDC 65841-058-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 7.5 mg

Rx only

100 tablets

NDC 65841-059-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 10 mg

Rx only

100 tablets

WARFARIN SODIUM
warfarin sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-052
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)	WARFARIN SODIUM	1 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	PINK (PINK)	Score	2 pieces
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	WAR;1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-052-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006
2	NDC:65841-052-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040663	06/19/2006

WARFARIN SODIUM
warfarin sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-053
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)	WARFARIN SODIUM	2 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	PURPLE (LAVENDER)	Score	2 pieces
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	WAR;2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-053-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006
2	NDC:65841-053-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040663	06/19/2006

WARFARIN SODIUM
warfarin sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-064
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)	WARFARIN SODIUM	2.5 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	GREEN (GREEN)	Score	2 pieces
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	WAR;2;1;2
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-064-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006
2	NDC:65841-064-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040663	06/19/2006

WARFARIN SODIUM
warfarin sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-054
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)	WARFARIN SODIUM	3 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	BROWN (TAN)	Score	2 pieces
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	WAR;3
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-054-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006
2	NDC:65841-054-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040663	06/19/2006

WARFARIN SODIUM
warfarin sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-055
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)	WARFARIN SODIUM	4 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	BLUE (BLUE)	Score	2 pieces
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	WAR;4
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-055-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006
2	NDC:65841-055-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040663	06/19/2006

WARFARIN SODIUM
warfarin sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-056
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)	WARFARIN SODIUM	5 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	ORANGE (PEACH)	Score	2 pieces
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	WAR;5
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-056-16	90 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006
2	NDC:65841-056-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006
3	NDC:65841-056-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040663	06/19/2006

WARFARIN SODIUM
warfarin sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-057
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)	WARFARIN SODIUM	6 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	GREEN (TEAL)	Score	2 pieces
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	WAR;6
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65841-057-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006
2	NDC:65841-057-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040663	06/19/2006

WARFARIN SODIUM
warfarin sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-058
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)	WARFARIN SODIUM	7.5 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	YELLOW (YELLOW)	Score	2 pieces
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	WAR;7;1;2
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-058-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040663	06/19/2006

WARFARIN SODIUM
warfarin sodium tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:65841-059
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)	WARFARIN SODIUM	10 mg

Ingredient Name	Strength
Inactive Ingredients
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	2 pieces
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	WAR;10
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65841-059-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/19/2006

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040663	06/19/2006

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		918596198	ANALYSIS(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)

WARFARIN SODIUM TABLETS, USP

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL