FDA.reportPublic FDA data

20 ML Empaveli 54 MG/ML Injection

RxCUI
2557391
RxNorm name
20 ML Empaveli 54 MG/ML Injection
Display name
20 ML Empaveli 54 MG/ML Injection
Full name
20 ML Empaveli 54 MG/ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:19

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

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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
EmpaveliPEGCETACOPLANApellis Pharmaceuticals, Inc.c23d89e9-b00b-4520-e053-2995a90a95af2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2557391

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
c23d89e9-b00b-4520-e053-2995a90a95afEMPAVELI 1080 MG in 20 ML Injection [PSN] · 20 ML pegcetacoplan 54 MG/ML Injection [Empaveli] [SBD] · 20 ML Empaveli 54 MG/ML Injection [SY] · Empaveli 1080 MG per 20 ML Injection [SY]413These highlights do not include all the information needed to use EMPAVELI safely and effectively. See full prescribing information for EMPAVELI. EMPAVELI ® (pegcetacoplan) injection, for subcutaneous use Initial U.S. Approval: 202120250730