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)Rx2026-08-01

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
KEVZARASARILUMABSanofi-Aventis U.S. LLC827bc01c-d379-4266-a18c-c7f904b76af32026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923347

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
827bc01c-d379-4266-a18c-c7f904b76af3KEVZARA 200 MG in 1.14 mL Prefilled Syringe [PSN] · 1.14 ML sarilumab 175 MG/ML Prefilled Syringe [Kevzara] [SBD] · 1.14 ML Kevzara 175 MG/ML Prefilled Syringe [SY] · Kevzara 200 MG per 1.14 ML Prefilled Syringe [SY]415These 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