FDA.reportPublic FDA data

UPLIZNA 100 MG per 10 ML Injection

RxCUI
2373960
RxNorm name
UPLIZNA 100 MG per 10 ML Injection
Display name
UPLIZNA 100 MG per 10 ML Injection
Full name
UPLIZNA 100 MG per 10 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761142Upliznainebilizumab-cdon351(a)Rx2026-08-01

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
UPLIZNAINEBILIZUMABHorizon Therapeutics USA, Inc.834db232-afb0-4dcf-93e0-009ce8245c202025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 2373960

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
834db232-afb0-4dcf-93e0-009ce8245c20UPLIZNA 100 MG in10 ML Injection [PSN] · 10 ML inebilizumab-cdon 10 MG/ML Injection [Uplizna] [SBD] · 10 ML Uplizna 10 MG/ML Injection [SY] · UPLIZNA 100 MG per 10 ML Injection [SY]49These highlights do not include all the information needed to use UPLIZNA ® safely and effectively. See full prescribing information for UPLIZNA ® . UPLIZNA ® (inebilizumab-cdon) injection, for intravenous use Initial U.S. Approval: 202020251211