Warfarin Sodium (Page 7 of 7)

WARFARIN SODIUM TABLET

Label Image
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Warfarin Sodium Tablets USP 1 mg, 100s Label Text

Laboratories, Inc. 0555- -02 barr
NDC 0831

Warfarin Sodium Tablets, USP

1 mg

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

Rx only 100 Tablets

WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64725-0833(NDC:0555-0833)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
HYPROMELLOSE 2208 (3 MPA.S)
MAGNESIUM STEARATE
STARCH, CORN
FD&C YELLOW NO. 6
ALUMINUM OXIDE
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 833;5;barr
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64725-0833-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040145 07/25/1997
Labeler — TYA Pharmaceuticals (938389038)
Registrant — TYA Pharmaceuticals (938389038)
Establishment
Name Address ID/FEI Operations
TYA Pharmaceuticals 938389038 RELABEL (64725-0833), REPACK (64725-0833)

Revised: 09/2012 TYA Pharmaceuticals

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