FDA.reportPublic FDA data

1 ML satralizumab-mwge 120 MG/ML Prefilled Syringe [Enspryng]

RxCUI
2391560
RxNorm name
1 ML satralizumab-mwge 120 MG/ML Prefilled Syringe [Enspryng]
Display name
1 ML satralizumab-mwge 120 MG/ML Prefilled Syringe [Enspryng]
Full name
1 ML satralizumab-mwge 120 MG/ML Prefilled Syringe [Enspryng]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:01

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761149Enspryngsatralizumab-mwge351(a)Rx2026-10-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
64c156a4-9bad-4d45-a294-0733c141f47bEnspryng 120 MG in 1 ML Prefilled Syringe [PSN] · 1 ML satralizumab-mwge 120 MG/ML Prefilled Syringe [Enspryng] [SBD] · 1 ML Enspryng 120 MG/ML Prefilled Syringe [SY] · Enspryng 120 MG per 1 ML Prefilled Syringe [SY]413These highlights do not include all the information needed to use ENSPRYNG safely and effectively. See full prescribing information for ENSPRYNG. ENSPRYNG ® (satralizumab-mwge) injection, for subcutaneous use Initial U.S. Approval: 202020251203