FDA.reportPublic FDA data

1.1 ML elranatamab-bcmm 40 MG/ML Injection [Elrexfio]

RxCUI
2644891
RxNorm name
1.1 ML elranatamab-bcmm 40 MG/ML Injection [Elrexfio]
Display name
1.1 ML elranatamab-bcmm 40 MG/ML Injection [Elrexfio]
Full name
1.1 ML elranatamab-bcmm 40 MG/ML Injection [Elrexfio]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:14

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761345Elrexfioelranatamab-bcmm351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ElrexfioELRANATAMAB-BCMMU.S. Pharmaceuticalsaa044060-5b4b-4692-bf0f-9a50e140b10e2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2644891
ElrexfioELRANATAMAB-BCMMPfizer Laboratories Div Pfizer Incf6fea598-ff58-4a20-b5e8-8a51f37d8beb2026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2644891

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
aa044060-5b4b-4692-bf0f-9a50e140b10e1.1 ML elranatamab-bcmm 40 MG/ML Injection [Elrexfio]SBD5These 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 use Initial U.S. Approval: 202320260514
aa044060-5b4b-4692-bf0f-9a50e140b10eElrexfio 44 MG per 1.1 ML InjectionSY5These 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 use Initial U.S. Approval: 202320260514
aa044060-5b4b-4692-bf0f-9a50e140b10eELREXFIO 44 MG in 1.1 ML InjectionPSN5These 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 use Initial U.S. Approval: 202320260514
aa044060-5b4b-4692-bf0f-9a50e140b10e1.1 ML Elrexfio 40 MG/ML InjectionSY5These 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 use Initial U.S. Approval: 202320260514
f6fea598-ff58-4a20-b5e8-8a51f37d8bebElrexfio 44 MG per 1.1 ML InjectionSY4These 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 use Initial U.S. Approval: 202320260226
f6fea598-ff58-4a20-b5e8-8a51f37d8beb1.1 ML elranatamab-bcmm 40 MG/ML Injection [Elrexfio]SBD4These 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 use Initial U.S. Approval: 202320260226
f6fea598-ff58-4a20-b5e8-8a51f37d8beb1.1 ML Elrexfio 40 MG/ML InjectionSY4These 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 use Initial U.S. Approval: 202320260226
f6fea598-ff58-4a20-b5e8-8a51f37d8bebELREXFIO 44 MG in 1.1 ML InjectionPSN4These 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 use Initial U.S. Approval: 202320260226