FDA.reportPublic FDA data

1 ML Benlysta 200 MG/ML Auto-Injector

RxCUI
1939299
RxNorm name
1 ML Benlysta 200 MG/ML Auto-Injector
Display name
1 ML Benlysta 200 MG/ML Auto-Injector
Full name
1 ML Benlysta 200 MG/ML Auto-Injector
Term type
SY
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: 1939299

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 Auto-Injector [PSN] · 1 ML belimumab 200 MG/ML Auto-Injector [Benlysta] [SBD] · 1 ML Benlysta 200 MG/ML Auto-Injector [SY] · Benlysta 200 MG per 1 ML Auto-Injector [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