FDA.reportPublic FDA data

2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [Spevigo]

RxCUI
2716697
RxNorm name
2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [Spevigo]
Display name
2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [Spevigo]
Full name
2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [Spevigo]
Term type
SBD
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)Rx2026-06-01

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: 2716697
SPEVIGOSPESOLIMABLEO Pharma Inc.78a4f7eb-8d34-4467-8d40-74ed243238062026-03-16Warnings, Adverse reactionsExact identifier
rxcui: 2716697

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
41a481ee-3062-45d1-aed5-17e8b105634d2 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [Spevigo]SBD6These 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
41a481ee-3062-45d1-aed5-17e8b105634dSpevigo 300 MG per 2 ML Prefilled SyringeSY6These 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
41a481ee-3062-45d1-aed5-17e8b105634dSpevigo 300 MG in 2 ML Prefilled SyringePSN6These 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-8d34-4467-8d40-74ed24323806Spevigo 300 MG per 2 ML Prefilled SyringeSY2These 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
78a4f7eb-8d34-4467-8d40-74ed243238062 ML spesolimab-sbzo 150 MG/ML Prefilled Syringe [Spevigo]SBD2These 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
78a4f7eb-8d34-4467-8d40-74ed24323806Spevigo 300 MG in 2 ML Prefilled SyringePSN2These 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