FDA.reportPublic FDA data

sarilumab 200 MG per 1.14 ML Prefilled Syringe

RxCUI
1923345
RxNorm name
sarilumab 200 MG per 1.14 ML Prefilled Syringe
Display name
sarilumab 200 MG per 1.14 ML Prefilled Syringe
Full name
sarilumab 200 MG per 1.14 ML Prefilled Syringe
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
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: 1923345

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-c7f904b76af3sarilumab 200 MG in 1.14 mL Prefilled Syringe [PSN] · 1.14 ML sarilumab 175 MG/ML Prefilled Syringe [SCD] · sarilumab 200 MG per 1.14 ML Prefilled Syringe [SY]315These 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