FDA.reportPublic FDA data

1 ML galcanezumab-gnlm 120 MG/ML Prefilled Syringe [Emgality]

RxCUI
2058887
RxNorm name
1 ML galcanezumab-gnlm 120 MG/ML Prefilled Syringe [Emgality]
Display name
1 ML galcanezumab-gnlm 120 MG/ML Prefilled Syringe [Emgality]
Full name
1 ML galcanezumab-gnlm 120 MG/ML Prefilled Syringe [Emgality]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761063Emgalitygalcanezumab-gnlm351(a)Rx2026-09-01

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
EMGALITYGALCANEZUMAB-GNLMEli Lilly and Company33a147be-233a-40e8-a55e-e40936e28db02026-06-05Warnings, Adverse reactionsExact identifier
rxcui: 2058887

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
33a147be-233a-40e8-a55e-e40936e28db0Emgality 120 MG in 1 ML Prefilled Syringe [PSN] · 1 ML galcanezumab-gnlm 120 MG/ML Prefilled Syringe [Emgality] [SBD] · Emgality 120 MG per 1 ML Prefilled Syringe [SY]315These highlights do not include all the information needed to use EMGALITY safely and effectively. See full prescribing information for EMGALITY. EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use Initial U.S. Approval: 201820251021