Elrexfio
These highlights do not include all the information needed to use ELREXFIO safely and effectively. See full prescribing information for ELREXFIO. ELREXFIO (elranatamab-bcmm) injection, for subcutaneous useInitial U.S. Approval: 2023
Approved
Approval ID
aa044060-5b4b-4692-bf0f-9a50e140b10e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2023
Manufacturers
FDA
U.S. Pharmaceuticals
DUNS: 829076905
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
elranatamab-bcmm
PRODUCT DETAILS
NDC Product Code63539-252
Application NumberBLA761345
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 16, 2023
Generic Nameelranatamab-bcmm
INGREDIENTS (7)
ELRANATAMABActive
Quantity: 44 mg in 1.1 mL
Code: L0HR9A577V
Classification: ACTIB
HISTIDINEInactive
Quantity: 1.23 mg in 1.1 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 2.94 mg in 1.1 mL
Code: X573657P6P
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.06 mg in 1.1 mL
Code: 7FLD91C86K
Classification: IACT
SUCROSEInactive
Quantity: 94 mg in 1.1 mL
Code: C151H8M554
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.2 mg in 1.1 mL
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT