STEARIC ACID
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
Product Characteristics
Color BLUE (greenish-blue) Score 2pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;6;G
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 51138-201-30 30TABLETIn1BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 01/20/2011
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51138-202(0378-8875)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin Sodium(Warfarin) Warfarin Sodium 7.5mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STEARIC ACID
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW Score 2pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;7;5;G
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 51138-202-30 30TABLETIn1BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 01/20/2011
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51138-203(0378-8810)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin Sodium(Warfarin) Warfarin Sodium 10mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STEARIC ACID
Product Characteristics
Color WHITE (white to off-white) Score 2pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;10;G
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 51138-203-30 30TABLETIn1BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 01/20/2011
Labeler -Med Health Pharma LLC.(962603812)
Registrant -Med Health Pharma LLC. (962603812)
Establishment
Name Address ID/FEI Operations
Med Health Pharma LLC. 962603812 repack