Warfarin Sodium

WARFARIN SODIUM — warfarin sodium tablet
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-052-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 1 mg

R_x only

100 tablets

NDC 65841-053-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 2 mg

R_x only

100 tablets

NDC 65841-064-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 2.5 mg

R_x only

100 tablets

NDC 65841-054-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 3 mg

R_x only

100 tablets

NDC 65841-055-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 4 mg

R_x only

100 tablets

NDC 65841-056-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 5 mg

R_x only

100 tablets

NDC 65841-057-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 6 mg

R_x only

100 tablets

NDC 65841-058-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 7.5 mg

R_x only

100 tablets

NDC 65841-059-01 in bottle of 100 tablets

Warfarin Sodium Tablets USP, 10 mg

R_x only

100 tablets

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 — Zydus Lifesciences Limited (918596198)

Registrant — Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences 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: 10/2022 Zydus Lifesciences Limited