FDA.reportPublic FDA data

1.14 ML sarilumab 175 MG/ML Prefilled Syringe [Kevzara]

RxCUI
1923347
RxNorm name
1.14 ML sarilumab 175 MG/ML Prefilled Syringe [Kevzara]
Display name
1.14 ML sarilumab 175 MG/ML Prefilled Syringe [Kevzara]
Full name
1.14 ML sarilumab 175 MG/ML Prefilled Syringe [Kevzara]
Term type
SBD
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
761037Kevzarasarilumab351(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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KEVZARASARILUMABSanofi-Aventis U.S. LLC827bc01c-d379-4266-a18c-c7f904b76af32026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923347

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
827bc01c-d379-4266-a18c-c7f904b76af31.14 ML sarilumab 175 MG/ML Prefilled Syringe [Kevzara]SBD15These highlights do not include all the information needed to use KEVZARA ® safely and effectively. See full prescribing information for KEVZARA. KEVZARA (sarilumab) injection, for subcutaneous use Initial U.S. Approval: 201720260227
827bc01c-d379-4266-a18c-c7f904b76af3KEVZARA 200 MG in 1.14 mL Prefilled SyringePSN15These highlights do not include all the information needed to use KEVZARA ® safely and effectively. See full prescribing information for KEVZARA. KEVZARA (sarilumab) injection, for subcutaneous use Initial U.S. Approval: 201720260227
827bc01c-d379-4266-a18c-c7f904b76af3Kevzara 200 MG per 1.14 ML Prefilled SyringeSY15These highlights do not include all the information needed to use KEVZARA ® safely and effectively. See full prescribing information for KEVZARA. KEVZARA (sarilumab) injection, for subcutaneous use Initial U.S. Approval: 201720260227
827bc01c-d379-4266-a18c-c7f904b76af31.14 ML Kevzara 175 MG/ML Prefilled SyringeSY15These highlights do not include all the information needed to use KEVZARA ® safely and effectively. See full prescribing information for KEVZARA. KEVZARA (sarilumab) injection, for subcutaneous use Initial U.S. Approval: 201720260227