FDA.reportPublic FDA data

2 ML lecanemab-irmb 100 MG/ML Injection [Leqembi]

RxCUI
2626153
RxNorm name
2 ML lecanemab-irmb 100 MG/ML Injection [Leqembi]
Display name
2 ML lecanemab-irmb 100 MG/ML Injection [Leqembi]
Full name
2 ML lecanemab-irmb 100 MG/ML Injection [Leqembi]
Term type
SBD
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: 2626153

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9d1ff786-e577-410a-a273-c4d7d0e4e9752 ML lecanemab-irmb 100 MG/ML Injection [Leqembi]SBD22These 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-c4d7d0e4e975LEQEMBI 200 MG in 2 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-c4d7d0e4e9752 ML Leqembi 100 MG/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-c4d7d0e4e975Leqembi 200 MG per 2 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