NDC Code(s) : 63629-4122-1, 63629-4122-2, 63629-4122-3, 63629-4122-4, 63629-4122-5, 63629-4122-6, 63629-4122-7, 63629-4122-8
Packager : Bryant Ranch Prepack

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:63629-4122(NDC:0555-0869)
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)
HYPROMELLOSE 2208 (3 MPA.S)(UNII: 9H4L916OBU)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color PURPLE (lavender) Score 2 pieces
Shape OVAL Size 11 mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-4122-130 in 1 BOTTLE Type 0: Not a Combination Product29/01/2010
2NDC:63629-4122-214 in 1 BOTTLE Type 0: Not a Combination Product29/01/2010
3NDC:63629-4122-390 in 1 BOTTLE Type 0: Not a Combination Product29/01/2010
4NDC:63629-4122-445 in 1 BOTTLE Type 0: Not a Combination Product29/01/2010
5NDC:63629-4122-550 in 1 BOTTLE Type 0: Not a Combination Product29/01/2010
6NDC:63629-4122-621 in 1 BOTTLE Type 0: Not a Combination Product29/01/2010
7NDC:63629-4122-760 in 1 BOTTLE Type 0: Not a Combination Product29/01/2010
8NDC:63629-4122-820 in 1 BOTTLE Type 0: Not a Combination Product29/01/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040145 07/25/1997 09/30/2017

PRINCIPAL DISPLAY PANEL

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