FDA.reportPublic FDA data

1.2 ML alemtuzumab 10 MG/ML Injection [Lemtrada]

RxCUI
1594663
RxNorm name
1.2 ML alemtuzumab 10 MG/ML Injection [Lemtrada]
Display name
1.2 ML alemtuzumab 10 MG/ML Injection [Lemtrada]
Full name
1.2 ML alemtuzumab 10 MG/ML Injection [Lemtrada]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103948Campathalemtuzumab351(a)Disc2026-07-01

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
LEMTRADAALEMTUZUMABGenzyme Corporation6236b0bc-82e9-4447-9a78-f57d947702692025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1594663

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
6236b0bc-82e9-4447-9a78-f57d94770269Lemtrada 12 MG in 1.2 ML Injection [PSN] · 1.2 ML alemtuzumab 10 MG/ML Injection [Lemtrada] [SBD] · Lemtrada 12 MG per 1.2 ML Injection [SY]326These highlights do not include all the information needed to use LEMTRADA safely and effectively. See full prescribing information for LEMTRADA. LEMTRADA ® (alemtuzumab) injection, for intravenous use Initial U.S. Approval: 200120251103