FDA.reportPublic FDA data

10 ML emapalumab-lzsg 5 MG/ML Injection [Gamifant]

RxCUI
2104622
RxNorm name
10 ML emapalumab-lzsg 5 MG/ML Injection [Gamifant]
Display name
10 ML emapalumab-lzsg 5 MG/ML Injection [Gamifant]
Full name
10 ML emapalumab-lzsg 5 MG/ML Injection [Gamifant]
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
761107Gamifantemapalumab-lzsg351(a)Rx2026-07-01

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
GAMIFANTEMAPALUMAB-LZSGSwedish Orphan Biovitrum AB (publ)a865e0ef-8685-4f69-8838-648c4f3bab472026-03-26Warnings, Adverse reactionsExact identifier
rxcui: 2104622

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
a865e0ef-8685-4f69-8838-648c4f3bab47Gamifant 50 MG in 10 ML Injection [PSN] · 10 ML emapalumab-lzsg 5 MG/ML Injection [Gamifant] [SBD] · 10 ML Gamifant 5 MG/ML Injection [SY] · Gamifant 50 MG per 10 ML Injection [SY]410These highlights do not include all the information needed to use GAMIFANT safely and effectively. See full prescribing information for GAMIFANT. GAMIFANT ® (emapalumab-lzsg) injection, for intravenous use Initial U.S. Approval: 201820260326