SUTENT
These highlights do not include all the information needed to use SUTENT safely and effectively. See full prescribing information for SUTENT. SUTENT (sunitinib malate) capsules, for oral use Initial U.S. Approval: 2006
Approved
Approval ID
a5d555f5-d66a-4f94-abcf-96fa6d71a32f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2022
Manufacturers
FDA
U.S. Pharmaceuticals
DUNS: 829076905
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sunitinib malate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-017
Application NumberNDA021938
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sunitinib malate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2021
FDA Product Classification
INGREDIENTS (13)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUNITINIB MALATEActive
Quantity: 12.5 mg in 1 1
Code: LVX8N1UT73
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Sunitinib malate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-019
Application NumberNDA021938
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sunitinib malate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2021
FDA Product Classification
INGREDIENTS (15)
SUNITINIB MALATEActive
Quantity: 50 mg in 1 1
Code: LVX8N1UT73
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT