SPRYCEL
These highlights do not include all the information needed to use SPRYCEL safely and effectively. See full prescribing information for SPRYCEL. SPRYCEL (dasatinib) tablets, for oral useInitial U.S. Approval: 2006
Approved
Approval ID
4764f37b-c9e6-4ede-bcc2-8a03b7c521df
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2023
Manufacturers
FDA
E.R. Squibb & Sons, L.L.C.
DUNS: 011550092
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dasatinib
PRODUCT DETAILS
NDC Product Code0003-0528
Application NumberNDA021986
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 15, 2018
Generic Namedasatinib
INGREDIENTS (9)
dasatinibActive
Quantity: 50 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
dasatinib
PRODUCT DETAILS
NDC Product Code0003-0524
Application NumberNDA021986
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 15, 2018
Generic Namedasatinib
INGREDIENTS (9)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
dasatinibActive
Quantity: 70 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
dasatinib
PRODUCT DETAILS
NDC Product Code0003-0527
Application NumberNDA021986
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 15, 2018
Generic Namedasatinib
INGREDIENTS (9)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
dasatinibActive
Quantity: 20 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
dasatinib
PRODUCT DETAILS
NDC Product Code0003-0852
Application NumberNDA021986
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 15, 2018
Generic Namedasatinib
INGREDIENTS (9)
dasatinibActive
Quantity: 100 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
dasatinib
PRODUCT DETAILS
NDC Product Code0003-0855
Application NumberNDA021986
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 15, 2018
Generic Namedasatinib
INGREDIENTS (9)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
dasatinibActive
Quantity: 80 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
dasatinib
PRODUCT DETAILS
NDC Product Code0003-0857
Application NumberNDA021986
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateNovember 15, 2018
Generic Namedasatinib
INGREDIENTS (9)
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
dasatinibActive
Quantity: 140 mg in 1 1
Code: RBZ1571X5H
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT