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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM(UNII: 6153CWM0CL)
(WARFARIN - UNII:5Q7ZVV76EI) 		WARFARIN SODIUM2 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-4028-330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/1999
2NDC:58118-4028-830 in 1 BLISTER PACK Type 0: Not a Combination Product15/07/1999
3NDC:58118-4028-01 in 1 PACKET Type 0: Not a Combination Product15/07/1999
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM(UNII: 6153CWM0CL)
(WARFARIN - UNII:5Q7ZVV76EI) 		WARFARIN SODIUM5 mg
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-4032-330 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/07/1999
2NDC:58118-4032-830 in 1 BLISTER PACK Type 0: Not a Combination Product15/07/1999
3NDC:58118-4032-01 in 1 PACKET Type 0: Not a Combination Product15/07/1999
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040301 07/15/1999 11/28/2017

PRINCIPAL DISPLAY PANEL

2mg Packer2mg Packer2mg Packer

PRINCIPAL DISPLAY PANEL

5mg Packet5mg Packet5mg Packet