FDA.reportPublic FDA data

0.8 ML anifrolumab-fnia 150 MG/ML Prefilled Syringe

RxCUI
2741478
RxNorm name
0.8 ML anifrolumab-fnia 150 MG/ML Prefilled Syringe
Display name
0.8 ML anifrolumab-fnia 150 MG/ML Prefilled Syringe
Full name
0.8 ML anifrolumab-fnia 150 MG/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761123Saphneloanifrolumab-fnia351(a)Rx2026-07-01
761451Saphneloanifrolumab-fnia351(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
SAPHNELOANIFROLUMAB-FNIAAstraZeneca Pharmaceuticals LPd6203302-2128-41a7-b0b4-0e6c0704d4dc2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 2741478

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
d6203302-2128-41a7-b0b4-0e6c0704d4dcanifrolumab-fnia 120 MG in 0.8 ML Prefilled Syringe [PSN] · 0.8 ML anifrolumab-fnia 150 MG/ML Prefilled Syringe [SCD] · anifrolumab-fnia 120 MG per 0.8 ML Prefilled Syringe [SY]315These highlights do not include all the information needed to use SAPHNELO ® safely and effectively. See full prescribing information for SAPHNELO. SAPHNELO (anifrolumab-fnia) injection, for intravenous, or subcutaneous use Initial U.S. Approval: 202120260424