Warfarin Sodium (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 5 mg

NDC 0378-8805-01

Warfarin Sodium
Tablets, USP
(Crystalline*)
5 mg

HIGHLY POTENT ANTICOAGULANT

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

Rx only 100 TABLETS

Each tablet contains:
Warfarin sodium, USP 5 mg

*Present as crystalline
sodium warfarin isopropanol
clathrate.

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F ).
[See USP Controlled Room
Temperature.]

Protect from light.

Usual Adult Dosage: See
accompanying prescribing
information.

PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

RM8805A3

Warfarin Sodium Tablets 5 mg Bottles
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 6 mg

NDC 0378-8806-01

Warfarin Sodium
Tablets, USP
(Crystalline*)
6 mg

HIGHLY POTENT ANTICOAGULANT

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

Rx only 100 TABLETS

Each tablet contains:
Warfarin sodium, USP 6 mg

*Present as crystalline
sodium warfarin isopropanol
clathrate.

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F ).
[See USP Controlled Room
Temperature.]

Protect from light.

Usual Adult Dosage: See
accompanying prescribing
information.

PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

RM8806A3

Warfarin Sodium Tablets 6 mg Bottles
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 7.5 mg

NDC 0378-8875-01

Warfarin Sodium
Tablets, USP
(Crystalline*)
7.5 mg

HIGHLY POTENT ANTICOAGULANT

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

Rx only 100 TABLETS

Each tablet contains:
Warfarin sodium, USP 7.5 mg

*Present as crystalline
sodium warfarin isopropanol
clathrate.

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F ).
[See USP Controlled Room
Temperature.]

Protect from light.

Usual Adult Dosage: See
accompanying prescribing
information.

PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

RM8875A3

Warfarin Sodium Tablets 7.5 mg Bottles
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg

NDC 0378-8810-01

Warfarin Sodium
Tablets, USP
(Crystalline*)
10 mg

HIGHLY POTENT ANTICOAGULANT

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

Rx only 100 TABLETS

Each tablet contains:
Warfarin sodium, USP 10 mg

*Present as crystalline
sodium warfarin isopropanol
clathrate.

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Store at 20° to 25°C (68° to 77°F ).
[See USP Controlled Room
Temperature.]

Protect from light.

Usual Adult Dosage: See
accompanying prescribing
information.

PHARMACIST: Dispense the
accompanying Medication
Guide to each patient.

Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

RM8810A3

Warfarin Sodium Tablets 10 mg Bottles
(click image for full-size original)
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8801
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
FD&C RED NO. 40
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STEARIC ACID
Product Characteristics
Color PINK (dark pink) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;1;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-8801-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-8801-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 12/27/2011
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8802
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
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STEARIC ACID
FD&C BLUE NO. 2
FD&C RED NO. 40
Product Characteristics
Color PURPLE (lavender) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;2;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-8802-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-8802-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 12/27/2011
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8825
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
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STEARIC ACID
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;2;5;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-8825-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-8825-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 12/27/2011
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8803
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
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STEARIC ACID
FD&C YELLOW NO. 6
FD&C BLUE NO. 2
FD&C RED NO. 40
Product Characteristics
Color WHITE (beige) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;3;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-8803-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-8803-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 12/27/2011
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8804
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
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STEARIC ACID
FD&C BLUE NO. 1
Product Characteristics
Color BLUE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;4;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-8804-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-8804-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 12/27/2011
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8805
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
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STEARIC ACID
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;5;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-8805-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-8805-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 12/27/2011
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8806
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 6 mg
Inactive Ingredients
Ingredient Name Strength
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STEARIC ACID
Product Characteristics
Color BLUE (greenish-blue) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;6;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-8806-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-8806-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 12/27/2011
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8875
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 7.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STEARIC ACID
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;7;5;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-8875-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-8875-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 12/27/2011
WARFARIN SODIUM warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-8810
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WARFARIN SODIUM (WARFARIN) WARFARIN SODIUM 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STEARIC ACID
Product Characteristics
Color WHITE (white to off-white) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code WF;10;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-8810-01 100 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0378-8810-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040415 12/27/2011
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 12/2011 Mylan Pharmaceuticals Inc.

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