FDA.reportPublic FDA data

Benlysta 200 MG in 1 ML Prefilled Syringe

RxCUI
1939348
RxNorm name
Benlysta 200 MG in 1 ML Prefilled Syringe
Display name
Benlysta 200 MG in 1 ML Prefilled Syringe
Full name
Benlysta 200 MG in 1 ML Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:52

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761043Benlystabelimumab351(a)Rx2026-08-01
125370Benlystabelimumab351(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
BENLYSTABELIMUMABGlaxoSmithKline LLC2fa3c528-1777-4628-8a55-a69dae2381a32026-08-21Warnings, Adverse reactionsExact identifier
rxcui: 1939348

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
2fa3c528-1777-4628-8a55-a69dae2381a3Benlysta 200 MG in 1 ML Prefilled Syringe [PSN] · 1 ML belimumab 200 MG/ML Prefilled Syringe [Benlysta] [SBD] · 1 ML Benlysta 200 MG/ML Prefilled Syringe [SY] · Benlysta 200 MG per 1 ML Prefilled Syringe [SY]437These highlights do not include all the information needed to use BENLYSTA safely and effectively. See full prescribing information for BENLYSTA. BENLYSTA (belimumab) for injection, for intravenous use BENLYSTA (belimumab) injection, for subcutaneous use Initial U.S. Approval: 201120250620