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| NDC | 65841-052-01, 65841-052-10, 65841-053-01, 65841-053-10, 65841-054-01, 65841-054-10, 65841-055-01, 65841-055-10, 65841-056-01, 65841-056-10, 65841-056-16, 65841-057-01, 65841-057-10, 65841-058-01, 65841-059-01, 65841-064-01, 65841-064-10 |
| Set ID | 3fb2aa58-3a40-4255-a261-e2db5b9a5dde |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | ANDA040663 |
- MEDICATION GUIDE
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-052-01 in bottle of 100 tablets
Warfarin Sodium Tablets USP, 1 mg
Rx only
100 tablets
NDC 65841-053-01 in bottle of 100 tablets
Warfarin Sodium Tablets USP, 2 mg
Rx only
100 tablets
NDC 65841-064-01 in bottle of 100 tablets
Warfarin Sodium Tablets USP, 2.5 mg
Rx only
100 tablets
NDC 65841-054-01 in bottle of 100 tablets
Warfarin Sodium Tablets USP, 3 mg
Rx only
100 tablets
NDC 65841-055-01 in bottle of 100 tablets
Warfarin Sodium Tablets USP, 4 mg
Rx only
100 tablets
NDC 65841-056-01 in bottle of 100 tablets
Warfarin Sodium Tablets USP, 5 mg
Rx only
100 tablets
NDC 65841-057-01 in bottle of 100 tablets
Warfarin Sodium Tablets USP, 6 mg
Rx only
100 tablets
NDC 65841-058-01 in bottle of 100 tablets
Warfarin Sodium Tablets USP, 7.5 mg
Rx only
100 tablets
NDC 65841-059-01 in bottle of 100 tablets
Warfarin Sodium Tablets USP, 10 mg
Rx only
100 tablets
-
INGREDIENTS AND APPEARANCE
WARFARIN SODIUM
warfarin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-052 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM 1 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 6 BARIUM LAKE (UNII: K4XZD9W99K) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color PINK (PINK) Score 2 pieces Shape OVAL (OVAL) Size 11mm Flavor Imprint Code WAR;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-052-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 2 NDC:65841-052-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040663 06/19/2006 WARFARIN SODIUM
warfarin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-053 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM 2 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) FD&C RED NO. 40 (UNII: WZB9127XOA) STARCH, CORN (UNII: O8232NY3SJ) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color PURPLE (LAVENDER) Score 2 pieces Shape OVAL (OVAL) Size 11mm Flavor Imprint Code WAR;2 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-053-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 2 NDC:65841-053-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040663 06/19/2006 WARFARIN SODIUM
warfarin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-064 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM 2.5 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) 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 Marketing Start Date Marketing End Date 1 NDC:65841-064-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 2 NDC:65841-064-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040663 06/19/2006 WARFARIN SODIUM
warfarin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-054 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM 3 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color BROWN (TAN) Score 2 pieces Shape OVAL (OVAL) Size 11mm Flavor Imprint Code WAR;3 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-054-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 2 NDC:65841-054-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040663 06/19/2006 WARFARIN SODIUM
warfarin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-055 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM 4 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color BLUE (BLUE) Score 2 pieces Shape OVAL (OVAL) Size 11mm Flavor Imprint Code WAR;4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-055-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 2 NDC:65841-055-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040663 06/19/2006 WARFARIN SODIUM
warfarin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-056 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM 5 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color ORANGE (PEACH) Score 2 pieces Shape OVAL (OVAL) Size 11mm Flavor Imprint Code WAR;5 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-056-16 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 2 NDC:65841-056-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 3 NDC:65841-056-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040663 06/19/2006 WARFARIN SODIUM
warfarin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-057 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM 6 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1--ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color GREEN (TEAL) Score 2 pieces Shape OVAL (OVAL) Size 11mm Flavor Imprint Code WAR;6 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-057-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 2 NDC:65841-057-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040663 06/19/2006 WARFARIN SODIUM
warfarin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-058 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM 7.5 mg Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) 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 Marketing Start Date Marketing End Date 1 NDC:65841-058-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040663 06/19/2006 WARFARIN SODIUM
warfarin sodium tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-059 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI) WARFARIN SODIUM 10 mg Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) 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 Marketing Start Date Marketing End Date 1 NDC:65841-059-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/19/2006 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 Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(65841-052, 65841-053, 65841-064, 65841-054, 65841-055, 65841-056, 65841-057, 65841-058, 65841-059) , MANUFACTURE(65841-052, 65841-053, 65841-064, 65841-054, 65841-055, 65841-056, 65841-057, 65841-058, 65841-059)