FDA.reportPublic FDA data

Kevzara 200 MG per 1.14 ML Auto-Injector

RxCUI
2003767
RxNorm name
Kevzara 200 MG per 1.14 ML Auto-Injector
Display name
Kevzara 200 MG per 1.14 ML Auto-Injector
Full name
Kevzara 200 MG per 1.14 ML Auto-Injector
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: 2003767

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 Auto-Injector [PSN] · 1.14 ML sarilumab 175 MG/ML Auto-Injector [Kevzara] [SBD] · 1.14 ML Kevzara 175 MG/ML Auto-Injector [SY] · Kevzara 200 MG per 1.14 ML Auto-Injector [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