KOSELUGO
These highlights do not include all the information needed to use KOSELUGO safely and effectively. See full prescribing information for KOSELUGO.KOSELUGO (selumetinib) capsules, for oral useInitial U.S. Approval: 2020
Approved
Approval ID
7d042c61-f28f-4ab5-ab10-d7558c0d49ff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SELUMETINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-0610
Application NumberNDA213756
Product Classification
M
Marketing Category
C73594
G
Generic Name
SELUMETINIB
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2021
FDA Product Classification
INGREDIENTS (13)
SELUMETINIBActive
Quantity: 10 mg in 1 1
Code: 6UH91I579U
Classification: ACTIB
TOCOPHERSOLANInactive
Code: O03S90U1F2
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SELUMETINIB
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-0625
Application NumberNDA213756
Product Classification
M
Marketing Category
C73594
G
Generic Name
SELUMETINIB
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2021
FDA Product Classification
INGREDIENTS (15)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SELUMETINIBActive
Quantity: 25 mg in 1 1
Code: 6UH91I579U
Classification: ACTIB
TOCOPHERSOLANInactive
Code: O03S90U1F2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
1-BUTANOL, 4-(ETHENYLOXY)-Inactive
Code: 8LGM5RZX0N
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERYL OLEATEInactive
Code: 4PC054V79P
Classification: IACT