FDA.reportPublic FDA data

lecanemab-irmb 500 MG in 5 ML Injection

RxCUI
2626155
RxNorm name
lecanemab-irmb 500 MG in 5 ML Injection
Display name
lecanemab-irmb 500 MG in 5 ML Injection
Full name
lecanemab-irmb 500 MG in 5 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761269Leqembilecanemab-irmb351(a)Rx2026-06-01
761375Leqembi IQLIKlecanemab-irmb351(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#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEQEMBILECANEMABEisai Inc.9d1ff786-e577-410a-a273-c4d7d0e4e9752026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2626155

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9d1ff786-e577-410a-a273-c4d7d0e4e975lecanemab-irmb 500 MG in 5 ML InjectionPSN22These highlights do not include all the information needed to use LEQEMBI ® safely and effectively. See full prescribing information for LEQEMBI ® . LEQEMBI ® (lecanemab-irmb) injection, for intravenous or subcutaneous use Initial U.S. Approval: 202320260123
9d1ff786-e577-410a-a273-c4d7d0e4e975lecanemab-irmb 500 MG per 5 ML InjectionSY22These highlights do not include all the information needed to use LEQEMBI ® safely and effectively. See full prescribing information for LEQEMBI ® . LEQEMBI ® (lecanemab-irmb) injection, for intravenous or subcutaneous use Initial U.S. Approval: 202320260123
9d1ff786-e577-410a-a273-c4d7d0e4e9755 ML lecanemab-irmb 100 MG/ML InjectionSCD22These highlights do not include all the information needed to use LEQEMBI ® safely and effectively. See full prescribing information for LEQEMBI ® . LEQEMBI ® (lecanemab-irmb) injection, for intravenous or subcutaneous use Initial U.S. Approval: 202320260123