Warfarin Sodium

WARFARIN SODIUM- warfarin sodium tablet
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-052-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 1 mg

Rx only

100 tablets

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

NDC 65841-053-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 2 mg

Rx only

100 tablets

Warfarin Sodium tablet
(click image for full-size original)

NDC 65841-064-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 2.5 mg

Rx only

100 tablets

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

NDC 65841-054-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 3 mg

Rx only

100 tablets

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

NDC 65841-055-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 4 mg

Rx only

100 tablets

warfarin sodium tablet
(click image for full-size original)

NDC 65841-056-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 5 mg

Rx only

100 tablets

warfarin sodium tablet
(click image for full-size original)

NDC 65841-057-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 6 mg

Rx only

100 tablets

warfarin sodium tablet
(click image for full-size original)

NDC 65841-058-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 7.5 mg

Rx only

100 tablets

warfarin sodium tablet
(click image for full-size original)

NDC 65841-059-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 10 mg

Rx only

100 tablets

warfarin sodium tablet
(click image for full-size original)
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-052
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 BARIUM LAKE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, 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:65841-052-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-052-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 06/19/2006
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-053
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–ALUMINUM LAKE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
FD&C RED NO. 40
STARCH, CORN
ALUMINUM OXIDE
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:65841-053-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-053-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 06/19/2006
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-064
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
ALUMINUM OXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1–ALUMINUM LAKE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, 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:65841-064-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-064-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 06/19/2006
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-054
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
ALUMINUM OXIDE
FD&C BLUE NO. 2–ALUMINUM LAKE
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, 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:65841-054-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-054-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 06/19/2006
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-055
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–ALUMINUM LAKE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, 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:65841-055-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-055-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 06/19/2006
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-056
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
ALUMINUM OXIDE
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color ORANGE (PEACH) Score 2 pieces
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code WAR;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-056-16 90 TABLET in 1 BOTTLE None
2 NDC:65841-056-01 100 TABLET in 1 BOTTLE None
3 NDC:65841-056-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 06/19/2006
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-057
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–ALUMINUM LAKE
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
ALUMINUM OXIDE
Product Characteristics
Color GREEN (TEAL) Score 2 pieces
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code WAR;6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-057-01 100 TABLET in 1 BOTTLE None
2 NDC:65841-057-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 06/19/2006
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-058
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
ALUMINUM OXIDE
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color YELLOW (YELLOW) Score 2 pieces
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code WAR;7;1;2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-058-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 06/19/2006
WARFARIN SODIUM
warfarin sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-059
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
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score 2 pieces
Shape OVAL (OVAL) Size 11mm
Flavor Imprint Code WAR;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-059-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040663 06/19/2006
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (65841-052), ANALYSIS (65841-053), ANALYSIS (65841-064), ANALYSIS (65841-054), ANALYSIS (65841-055), ANALYSIS (65841-056), ANALYSIS (65841-057), ANALYSIS (65841-058), ANALYSIS (65841-059), MANUFACTURE (65841-052), MANUFACTURE (65841-053), MANUFACTURE (65841-064), MANUFACTURE (65841-054), MANUFACTURE (65841-055), MANUFACTURE (65841-056), MANUFACTURE (65841-057), MANUFACTURE (65841-058), MANUFACTURE (65841-059)

Revised: 09/2020 Cadila Healthcare Limited

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