Warfarin Sodium (Page 9 of 9)

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Warfarin Sodium Tablets USP 10 mg 100s Label Text

NDC 0093-1720 -01

Warfarin Sodium

Tablets USP, 10 mg

HIGHLY POTENT ANTICOAGULANT

WARNING: Serious bleeding results
from overdosage. Do not use or
dispense before reading directions and
warnings in package insert.

PHARMACIST: Dispense the accompanyingMedication Guide to each patient.

Rx only

100 TABLETS

TEVA

WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-235(NDC:0093-1715)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 3 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
FD&C RED NO. 40
D&C YELLOW NO. 10
Product Characteristics
Color BROWN (tan) Score 2 pieces
Shape OVAL (capsule-shaped) Size 11mm
Flavor Imprint Code TV;3;1715
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-235-30 30 TABLET in 1 BOTTLE None
2 NDC:53217-235-60 60 TABLET in 1 BOTTLE None
3 NDC:53217-235-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040616 07/14/2015
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 02/2017 Aidarex Pharmaceuticals LLC

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