NDC Code(s) : 49349-041-02
Packager : REMEDYREPACK INC.

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:49349-041(NDC:0555-0925)
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
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)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
ALUMINUM OXIDE(UNII: LMI26O6933)
Product Characteristics
Color brown (tan) Score 2 pieces
Shape OVAL Size 11 mm
Flavor Imprint Code 925;3;barr
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-041-0230 in 1 BLISTER PACK Type 0: Not a Combination Product29/09/2009
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040145 09/29/2009 04/15/2016

PRINCIPAL DISPLAY PANEL

DRUG: Warfarin Sodium

GENERIC: Warfarin Sodium

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 49349-041-02

COLOR: brown

SHAPE: OVAL

SCORE: Two even pieces

SIZE: 11 mm

IMPRINT: 925;3;barr

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • WARFARIN SODIUM 3mg in 1

INACTIVE INGREDIENT(S):

  • ALUMINUM OXIDE
  • FD&C RED NO. 40
  • FD&C BLUE NO. 2
  • FD&C YELLOW NO. 6
  • ANHYDROUS LACTOSE
  • HYPROMELLOSE 2208 (3 MPA.S)
  • MAGNESIUM STEARATE
  • STARCH, CORN

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