NDC 58118-4028-3
API & Excipient Details

Warfarin Sodium marketed by Clinical Solutions Wholesale under NDC Code 58118-4028-3

NDC Code(s) : 58118-4028-3, 58118-4028-8, 58118-4028-0, 58118-4032-3, 58118-4032-8, 58118-4032-0
Packager : Clinical Solutions Wholesale

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Warfarin SodiumWarfarin Sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:58118-4028(NDC:51672-4028)
Route of Administration	ORAL	DEA Schedule

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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
ALUMINUM OXIDE(UNII: LMI26O6933)

Product Characteristics
Color	purple (Lavender)	Score	2 pieces
Shape	OVAL (Flat beveled capsule shaped)	Size	11 mm
Flavor		Imprint Code	2;WARFARIN;TARO
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58118-4028-3	30 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	15/07/1999
2	NDC:58118-4028-8	30 in 1 BLISTER PACK Type 0: Not a Combination Product	15/07/1999
3	NDC:58118-4028-0	1 in 1 PACKET Type 0: Not a Combination Product	15/07/1999

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040301	07/15/1999	11/28/2017

Warfarin SodiumWarfarin Sodium TABLET

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:58118-4032(NDC:51672-4032)
Route of Administration	ORAL	DEA Schedule

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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM STEARATE(UNII: 70097M6I30)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALUMINUM OXIDE(UNII: LMI26O6933)
D&C RED NO. 6(UNII: 481744AI4O)
BARIUM OXIDE(UNII: 77603K202B)

Product Characteristics
Color	orange (Peach)	Score	2 pieces
Shape	OVAL (Flat beveled capsule shaped)	Size	11 mm
Flavor		Imprint Code	5;WARFARIN;TARO
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58118-4032-3	30 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product	15/07/1999
2	NDC:58118-4032-8	30 in 1 BLISTER PACK Type 0: Not a Combination Product	15/07/1999
3	NDC:58118-4032-0	1 in 1 PACKET Type 0: Not a Combination Product	15/07/1999

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040301	07/15/1999	11/28/2017

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL