Label: DASATINIB tablet
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NDC Code(s):
70771-1901-6,
70771-1902-6,
70771-1903-6,
70771-1904-3, view more70771-1905-3, 70771-1906-3
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 4, 2025
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Dasatinib Tablets, 20 mg
60 Tablets
Rx only
Zydus
Dasatinib Tablets, 50 mg
60 Tablets
Rx only
Zydus
Dasatinib Tablets, 70 mg
60 Tablets
Rx only
Zydus
Dasatinib Tablets, 80 mg
30 Tablets
Rx only
Zydus
Dasatinib Tablets, 100 mg
30 Tablets
Rx only
Zydus
Dasatinib Tablets, 140 mg
30 Tablets
Rx only
Zydus
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INGREDIENTS AND APPEARANCE
DASATINIB
dasatinib tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1901 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN) DASATINIB 20 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code 1741 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1901-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218719 03/03/2025 DASATINIB
dasatinib tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1902 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN) DASATINIB 50 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL Size 11mm Flavor Imprint Code 1742 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1902-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218719 03/03/2025 DASATINIB
dasatinib tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1903 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN) DASATINIB 70 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 9mm Flavor Imprint Code 1743 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1903-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218719 03/03/2025 DASATINIB
dasatinib tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1904 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN) DASATINIB 80 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL (oblong) Size 12mm Flavor Imprint Code 1744 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1904-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218719 03/03/2025 DASATINIB
dasatinib tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1905 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN) DASATINIB 100 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (white to off-white) Score no score Shape OVAL Size 15mm Flavor Imprint Code 1745 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1905-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218719 03/03/2025 DASATINIB
dasatinib tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1906 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN) DASATINIB 140 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 12mm Flavor Imprint Code 1746 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1906-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA218719 03/03/2025 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1901, 70771-1902, 70771-1903, 70771-1904, 70771-1905, 70771-1906) , MANUFACTURE(70771-1901, 70771-1902, 70771-1903, 70771-1904, 70771-1905, 70771-1906)