DASATINIB
These highlights do not include all the information needed to use DASATINIB TABLETS safely and effectively. See full prescribing information for DASATINIB TABLETS. DASATINIB tablets, for oral use Initial U.S. Approval: 2006
Approved
Approval ID
58ce42c6-10bd-4bb4-bf89-eae8ed82c339
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2024
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DASATINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-545
Application NumberANDA216547
Product Classification
M
Marketing Category
C73584
G
Generic Name
DASATINIB
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2024
FDA Product Classification
INGREDIENTS (9)
DASATINIBActive
Quantity: 80 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DASATINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-546
Application NumberANDA216547
Product Classification
M
Marketing Category
C73584
G
Generic Name
DASATINIB
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2024
FDA Product Classification
INGREDIENTS (9)
DASATINIBActive
Quantity: 100 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DASATINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-547
Application NumberANDA216547
Product Classification
M
Marketing Category
C73584
G
Generic Name
DASATINIB
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2024
FDA Product Classification
INGREDIENTS (9)
DASATINIBActive
Quantity: 140 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DASATINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-544
Application NumberANDA216547
Product Classification
M
Marketing Category
C73584
G
Generic Name
DASATINIB
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2024
FDA Product Classification
INGREDIENTS (9)
DASATINIBActive
Quantity: 70 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DASATINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-542
Application NumberANDA216547
Product Classification
M
Marketing Category
C73584
G
Generic Name
DASATINIB
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2024
FDA Product Classification
INGREDIENTS (9)
DASATINIBActive
Quantity: 20 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DASATINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-543
Application NumberANDA216547
Product Classification
M
Marketing Category
C73584
G
Generic Name
DASATINIB
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2024
FDA Product Classification
INGREDIENTS (9)
DASATINIBActive
Quantity: 50 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
MICROCRYSTALLINE CELLULOSE 112Inactive
Code: X7XJ6RM9Q2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT