NDC Code(s) : 52125-099-02
Packager : REMEDYREPACK INC.

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:52125-099(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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, TAPIOCA(UNII: 24SC3U704I)
MAGNESIUM STEARATE(UNII: 70097M6I30)
D&C RED NO. 6(UNII: 481744AI4O)
BARIUM SULFATE(UNII: 25BB7EKE2E)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
ALUMINUM HYDROXIDE-GLYCINE (2:1)(UNII: E9L1NA800E)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color pink Score 2 pieces
Shape ROUND (TABLET) Size 9 mm
Flavor Imprint Code 1;COUMADIN
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-099-0230 in 1 BLISTER PACK Type 0: Not a Combination Product19/07/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA009218 07/19/2012 12/11/2013

PRINCIPAL DISPLAY PANEL

DRUG: COUMADIN

GENERIC: warfarin sodium

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-099-02

STRENGTH:1 mg

COLOR: pink

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 9 mm

IMPRINT: 30

QTY: 30




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