LUMAKRAS
These highlights do not include all the information needed to use LUMAKRAS safely and effectively. See full prescribing information for LUMAKRAS. LUMAKRAS (sotorasib) tablets, for oral use Initial U.S. Approval: 2021
Approved
Approval ID
c80a362c-7ac3-4894-a076-0691e68ef8c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2023
Manufacturers
FDA
Amgen Inc
DUNS: 039976196
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sotorasib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-504
Application NumberNDA214665
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotorasib
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (5)
SOTORASIBActive
Quantity: 320 mg in 1 1
Code: 2B2VM6UC8G
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
sotorasib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55513-488
Application NumberNDA214665
Product Classification
M
Marketing Category
C73594
G
Generic Name
sotorasib
Product Specifications
Route of AdministrationORAL
Effective DateApril 27, 2023
FDA Product Classification
INGREDIENTS (5)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SOTORASIBActive
Quantity: 120 mg in 1 1
Code: 2B2VM6UC8G
Classification: ACTIB