NDC Code(s) : 69189-0675-5
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

COUMADINwarfarin sodium TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0675(NDC:0056-0169)
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
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
starch, tapioca(UNII: 24SC3U704I)
magnesium stearate(UNII: 70097M6I30)
D&C Red No. 6(UNII: 481744AI4O)
barium sulfate(UNII: 25BB7EKE2E)
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code 1;COUMADIN
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-0675-50.5 in 1 DOSE PACK Type 0: Not a Combination Product15/07/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009218 07/15/2016

PRINCIPAL DISPLAY PANEL

Warfarin 0.5 mg half tablet