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
f6fea598-ff58-4a20-b5e8-8a51f37d8beb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
elranatamab-bcmm
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-4494
Application NumberBLA761345
Product Classification
M
Marketing Category
C73585
G
Generic Name
elranatamab-bcmm
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2023
FDA Product Classification
INGREDIENTS (7)
HISTIDINEInactive
Quantity: 2.13 mg in 1.9 mL
Code: 4QD397987E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 5.07 mg in 1.9 mL
Code: X573657P6P
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.4 mg in 1.9 mL
Code: 6OZP39ZG8H
Classification: IACT
ELRANATAMABActive
Quantity: 76 mg in 1.9 mL
Code: L0HR9A577V
Classification: ACTIB
SUCROSEInactive
Quantity: 162 mg in 1.9 mL
Code: C151H8M554
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1.9 mL
Code: 7FLD91C86K
Classification: IACT
elranatamab-bcmm
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-2522
Application NumberBLA761345
Product Classification
M
Marketing Category
C73585
G
Generic Name
elranatamab-bcmm
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateAugust 15, 2023
FDA Product Classification
INGREDIENTS (7)
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 2.94 mg in 1.1 mL
Code: X573657P6P
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.2 mg in 1.1 mL
Code: 6OZP39ZG8H
Classification: IACT
EDETATE DISODIUMInactive
Quantity: 0.06 mg in 1.1 mL
Code: 7FLD91C86K
Classification: IACT
ELRANATAMABActive
Quantity: 44 mg in 1.1 mL
Code: L0HR9A577V
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Quantity: 94 mg in 1.1 mL
Code: C151H8M554
Classification: IACT
HISTIDINEInactive
Quantity: 1.23 mg in 1.1 mL
Code: 4QD397987E
Classification: IACT