NDC Code(s) : 35356-582-30, 35356-582-60, 35356-582-90, 35356-397-30, 35356-397-60, 35356-397-90, 35356-571-30, 35356-571-60, 35356-571-90, 35356-906-30, 35356-906-60, 35356-906-90
Packager : Lake Erie Medical DBA Quality Care Products LLC

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:35356-582(NDC:68382-052)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM(UNII: 6153CWM0CL)
(WARFARIN - UNII:5Q7ZVV76EI) 		WARFARIN SODIUM1 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 6(UNII: 481744AI4O)
HYDROXYPROPYL CELLULOSE(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 11 mm
Flavor Imprint Code WAR;1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-582-3030 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
2NDC:35356-582-6060 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
3NDC:35356-582-9090 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 05/30/2006 06/01/2016
Warfarin SodiumWarfarin Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-397(NDC:68382-064)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM(UNII: 6153CWM0CL)
(WARFARIN - UNII:5Q7ZVV76EI) 		WARFARIN SODIUM2.5 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color GREEN Score 2 pieces
Shape OVAL Size 11 mm
Flavor Imprint Code WAR;2;1;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-397-3030 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
2NDC:35356-397-6060 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
3NDC:35356-397-9090 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 05/30/2006 06/01/2016
Warfarin SodiumWarfarin Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-571(NDC:68382-053)
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
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color PURPLE Score 2 pieces
Shape OVAL Size 11 mm
Flavor Imprint Code WAR;2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-571-3030 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
2NDC:35356-571-6060 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
3NDC:35356-571-9090 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 05/30/2006 06/01/2016
Warfarin SodiumWarfarin Sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-906(NDC:68382-054)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM(UNII: 6153CWM0CL)
(WARFARIN - UNII:5Q7ZVV76EI) 		WARFARIN SODIUM3 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color BROWN Score 2 pieces
Shape OVAL Size 11 mm
Flavor Imprint Code WAR;3
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-906-3030 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
2NDC:35356-906-6060 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
3NDC:35356-906-9090 in 1 BOTTLE Type 1: Convenience Kit of Co-Package30/05/2006
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 05/30/2006 06/01/2016

PRINCIPAL DISPLAY PANEL

Image of 1mg Label

PRINCIPAL DISPLAY PANEL

Image of 2.5mg Label

PRINCIPAL DISPLAY PANEL

Image of 2mg Label

PRINCIPAL DISPLAY PANEL

Image of 3mg Label