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)Rx2026-07-01

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
EnspryngSATRALIZUMABGenentech, Inc.64c156a4-9bad-4d45-a294-0733c141f47b2026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 2391560

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