DailyMed - DASATINIB tablet

NDC Code(s): 70771-1901-6, 70771-1902-6, 70771-1903-6, 70771-1904-3, view more
70771-1905-3, 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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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1901-6 - Dasatinib Tablets, 20 mg - 60 Tablets - Rx only - Zydus - NDC 70771-1902-6 - Dasatinib Tablets, 50 mg - 60 Tablets - Rx only - Zydus - NDC 70771-1903-6 - Dasatinib Tablets, 70 mg - 60 Tablets - Rx ...

NDC 70771-1901-6

Dasatinib Tablets, 20 mg

60 Tablets

Rx only

Zydus

NDC 70771-1902-6

Dasatinib Tablets, 50 mg

60 Tablets

Rx only

Zydus

NDC 70771-1903-6

Dasatinib Tablets, 70 mg

60 Tablets

Rx only

Zydus

NDC 70771-1904-3

Dasatinib Tablets, 80 mg

30 Tablets

Rx only

Zydus

NDC 70771-1905-3

Dasatinib Tablets, 100 mg

30 Tablets

Rx only

Zydus

NDC 70771-1906-3

Dasatinib Tablets, 140 mg

30 Tablets

Rx only

Zydus

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INGREDIENTS AND APPEARANCE

Product Information

DASATINIB dasatinib tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1901
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN)	DASATINIB	20 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1901-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA218719	03/03/2025

DASATINIB dasatinib tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1902
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN)	DASATINIB	50 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1902-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA218719	03/03/2025

DASATINIB dasatinib tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1903
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN)	DASATINIB	70 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1903-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA218719	03/03/2025

DASATINIB dasatinib tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1904
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN)	DASATINIB	80 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1904-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA218719	03/03/2025

DASATINIB dasatinib tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1905
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN)	DASATINIB	100 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1905-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA218719	03/03/2025

DASATINIB dasatinib tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1906
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DASATINIB (UNII: RBZ1571X5H) (DASATINIB ANHYDROUS - UNII:X78UG0A0RN)	DASATINIB	140 mg

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1906-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/03/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA218719	03/03/2025

Labeler - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
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)

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Label: DASATINIB tablet

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	NDC
1	70771-1901-6
2	70771-1902-6
3	70771-1903-6
4	70771-1904-3
5	70771-1905-3
6	70771-1906-3

Label: DASATINIB tablet

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DASATINIB tablet

Number of versions: 1

DASATINIB tablet

DASATINIB tablet

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DASATINIB tablet

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.