FDA.reportPublic FDA data

2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe

RxCUI
2716696
RxNorm name
2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe
Display name
2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe
Full name
2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:55

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761244Spevigospesolimab-sbzo351(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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPEVIGOSPESOLIMAB-SBZOBoehringer Ingelheim Pharmaceuticals, Inc.41a481ee-3062-45d1-aed5-17e8b105634d2026-04-08Warnings, Adverse reactionsExact identifier
rxcui: 2716696
SPEVIGOSPESOLIMABLEO Pharma Inc.78a4f7eb-8d34-4467-8d40-74ed243238062026-03-16Warnings, Adverse reactionsExact identifier
rxcui: 2716696

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
41a481ee-3062-45d1-aed5-17e8b105634dspesolimab-sbzo 300 MG in 2 ML Prefilled Syringe [PSN] · 2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [SCD] · spesolimab-sbzo 300 MG per 2 ML Prefilled Syringe [SY]36These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 202220251027
78a4f7eb-8d34-4467-8d40-74ed24323806spesolimab-sbzo 300 MG in 2 ML Prefilled Syringe [PSN] · 2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [SCD] · spesolimab-sbzo 300 MG per 2 ML Prefilled Syringe [SY]32These highlights do not include all the information needed to use SPEVIGO safely and effectively. See full prescribing information for SPEVIGO. SPEVIGO ® (spesolimab-sbzo) injection, for subcutaneous or intravenous use Initial U.S. Approval: 202220260316