FDA.reportPublic FDA data

sutimlimab-jome 1100 MG in 22 ML Injection

RxCUI
2591419
RxNorm name
sutimlimab-jome 1100 MG in 22 ML Injection
Display name
sutimlimab-jome 1100 MG in 22 ML Injection
Full name
sutimlimab-jome 1100 MG in 22 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:51

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761164Enjaymosutimlimab-jome351(a)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EnjaymoSUTIMLIMAB-JOMERecordati Rare Diseases, Inc.0a25363a-7781-d9f8-cb1c-be22987bf03b2026-03-02Warnings, Adverse reactionsExact identifier
rxcui: 2591419

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
281cf1d4-6296-4416-858e-9bff46d01b71sutimlimab-jome 1100 MG per 22 ML InjectionSY10These highlights do not include all the information needed to use ENJAYMO safely and effectively. See full prescribing information for ENJAYMO. ENJAYMO ® (sutimlimab-jome) injection, for intravenous use Initial U.S. Approval: 202220240221
281cf1d4-6296-4416-858e-9bff46d01b7122 ML sutimlimab-jome 50 MG/ML InjectionSCD10These highlights do not include all the information needed to use ENJAYMO safely and effectively. See full prescribing information for ENJAYMO. ENJAYMO ® (sutimlimab-jome) injection, for intravenous use Initial U.S. Approval: 202220240221
281cf1d4-6296-4416-858e-9bff46d01b71sutimlimab-jome 1100 MG in 22 ML InjectionPSN10These highlights do not include all the information needed to use ENJAYMO safely and effectively. See full prescribing information for ENJAYMO. ENJAYMO ® (sutimlimab-jome) injection, for intravenous use Initial U.S. Approval: 202220240221
0a25363a-7781-d9f8-cb1c-be22987bf03b22 ML sutimlimab-jome 50 MG/ML InjectionSCD4These highlights do not include all the information needed to use ENJAYMO safely and effectively. See full prescribing information for ENJAYMO. ENJAYMO ® (sutimlimab-jome) injection, for intravenous use Initial U.S. Approval: 202220260302
0a25363a-7781-d9f8-cb1c-be22987bf03bsutimlimab-jome 1100 MG per 22 ML InjectionSY4These highlights do not include all the information needed to use ENJAYMO safely and effectively. See full prescribing information for ENJAYMO. ENJAYMO ® (sutimlimab-jome) injection, for intravenous use Initial U.S. Approval: 202220260302
0a25363a-7781-d9f8-cb1c-be22987bf03bsutimlimab-jome 1100 MG in 22 ML InjectionPSN4These highlights do not include all the information needed to use ENJAYMO safely and effectively. See full prescribing information for ENJAYMO. ENJAYMO ® (sutimlimab-jome) injection, for intravenous use Initial U.S. Approval: 202220260302