Warfarin Sodium (Page 9 of 9)

PACKAGE LABEL — WARFARIN SODIUM 2.5 MG TABLETS

WARFARIN SOD 2.5 MG LABEL Image
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PACKAGE LABEL — WARFARIN SODIUM 5 MG TABLETS

WARFARIN SOD 5 MG LABEL Image
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WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-340(NDC:51672-4029)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Warfarin Sodium (Warfarin) Warfarin Sodium 2.5 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose
starch, corn
magnesium stearate
FD&C Blue No. 2
D&C Yellow No. 10
Aluminum Oxide
Product Characteristics
Color GREEN Score 2 pieces
Shape OVAL (Flat beveled capsule shaped) Size 11mm
Flavor Imprint Code 2;1;2;WARFARIN;TARO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-340-30 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:16590-340-40 40 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040301 07/15/1999
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-341(NDC:51672-4032)
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
starch, corn
magnesium stearate
D&C Yellow No. 10
Aluminum Oxide
D&C Red No. 6
Barium Oxide
Product Characteristics
Color ORANGE (Peach) Score 2 pieces
Shape OVAL (Flat beveled capsule shaped) Size 11mm
Flavor Imprint Code 5;WARFARIN;TARO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-341-30 30 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040301 07/15/1999
Labeler — STAT Rx USA LLC (786036330)
Registrant — PSS World Medical Inc. (101822682)
Establishment
Name Address ID/FEI Operations
STAT Rx USA LLC 786036330 relabel (16590-340), repack (16590-340), relabel (16590-341), repack (16590-341)

Revised: 09/2012 STAT Rx USA LLC

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