Warfarin Sodium (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Warfarin Sodium Tablets USP, 1 mg

Rx only

Warfarin sodium 1 mg tablets
(click image for full-size original)

Warfarin Sodium Tablets USP, 2 mg

Rx only

Warfarin Sodium 2 mg tablets
(click image for full-size original)

Warfarin Sodium Tablets USP, 2.5 mg

Rx only

Warfarin Sodium 2.5 mg tablets
(click image for full-size original)

Warfarin Sodium Tablets USP, 3 mg

Rx only

Warfarin Sodium 3 mg tablets
(click image for full-size original)

Warfarin Sodium Tablets USP, 4 mg

Rx only

warfarin sodium 4 mg tablets
(click image for full-size original)
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4349(NDC:68382-052)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 1 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 6
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
Product Characteristics
Color PINK (PINK) Score 2 pieces
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code WAR;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4349-0 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-4349-1 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-4349-2 15 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-4349-3 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:54868-4349-5 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 11/15/2000
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4422(NDC:68382-053)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 2 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 2
FD&C RED NO. 4
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
Product Characteristics
Color PURPLE (LAVENDER) Score 2 pieces
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code WAR;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4422-0 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-4422-1 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-4422-2 15 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-4422-3 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:54868-4422-4 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
6 NDC:54868-4422-5 10 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 11/15/2000
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4400(NDC:68382-064)
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
D&C YELLOW NO. 10
FD&C BLUE NO. 1
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
Product Characteristics
Color GREEN (GREEN) Score 2 pieces
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code WAR;2;1;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4400-0 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-4400-1 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-4400-2 15 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-4400-3 45 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:54868-4400-4 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 11/14/2000
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4871(NDC:68382-054)
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
FD&C BLUE NO. 2
FD&C RED NO. 4
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
Product Characteristics
Color BROWN (TAN) Score 2 pieces
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code WAR;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4871-0 15 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-4871-1 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-4871-2 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-4871-3 90 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 08/06/2003
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4402(NDC:68382-055)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 4 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
HYDROXYPROPYL CELLULOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
Product Characteristics
Color BLUE (BLUE) Score 2 pieces
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code WAR;4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-4402-0 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-4402-1 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-4402-2 60 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-4402-3 15 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 11/15/2000
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 03/2012 Physicians Total Care, Inc.

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