Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Pfizer Laboratories Div Pfizer Inc
174350868
Pharmacia & Upjohn Company LLC
Pfizer Laboratories Div Pfizer Inc
618054084
PPD Development, L.P.
Pfizer Laboratories Div Pfizer Inc
838082055
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Elrexfio
Product Details
NDC Product Code
0069-4494Application Number
BLA761345Marketing Category
BLA (C73585)Route of Administration
SUBCUTANEOUSEffective Date
August 15, 2023HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 2.13 mg in 1.9 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACTQuantity: 5.07 mg in 1.9 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 0.4 mg in 1.9 mL
ElranatamabActive
Code: L0HR9A577VClass: ACTIBQuantity: 76 mg in 1.9 mL
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 162 mg in 1.9 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.1 mg in 1.9 mL
Elrexfio
Product Details
NDC Product Code
0069-2522Application Number
BLA761345Marketing Category
BLA (C73585)Route of Administration
SUBCUTANEOUSEffective Date
August 15, 2023HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACTQuantity: 2.94 mg in 1.1 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACTQuantity: 0.2 mg in 1.1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.06 mg in 1.1 mL
ElranatamabActive
Code: L0HR9A577VClass: ACTIBQuantity: 44 mg in 1.1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACTQuantity: 94 mg in 1.1 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 1.23 mg in 1.1 mL