FDA.reportPublic FDA data

Saphnelo 300 MG per 2 ML Injection

RxCUI
2565286
RxNorm name
Saphnelo 300 MG per 2 ML Injection
Display name
Saphnelo 300 MG per 2 ML Injection
Full name
Saphnelo 300 MG per 2 ML Injection
Term type
SY
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)Rx2026-08-01
761451Saphneloanifrolumab-fnia351(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
SAPHNELOANIFROLUMAB-FNIAAstraZeneca Pharmaceuticals LPd6203302-2128-41a7-b0b4-0e6c0704d4dc2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 2565286

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-b0b4-0e6c0704d4dcSaphnelo 300 MG in 2 ML Injection [PSN] · 2 ML anifrolumab-fnia 150 MG/ML Injection [Saphnelo] [SBD] · 2 ML Saphnelo 150 MG/ML Injection [SY] · Saphnelo 300 MG per 2 ML Injection [SY]415These 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