FDA.reportPublic FDA data

ropeginterferon alfa-2b-njft 500 MCG per 1 ML Prefilled Syringe

RxCUI
2587064
RxNorm name
ropeginterferon alfa-2b-njft 500 MCG per 1 ML Prefilled Syringe
Display name
ropeginterferon alfa-2b-njft 500 MCG per 1 ML Prefilled Syringe
Full name
ropeginterferon alfa-2b-njft 500 MCG per 1 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:09

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761166Besremiropeginterferon alfa-2b-njft351(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
BESREMiROPEGINTERFERON ALFA-2BPharmaEssentia USA9583405d-53a0-49dc-88eb-5e6384ebabcb2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2587064

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
9583405d-53a0-49dc-88eb-5e6384ebabcbropeginterferon alfa-2b-njft 500 MCG in 1 ML Prefilled Syringe [PSN] · 1 ML ropeginterferon alfa-2b-njft 0.5 MG/ML Prefilled Syringe [SCD] · ropeginterferon alfa-2b-njft 500 MCG per 1 ML Prefilled Syringe [SY]311These highlights do not include all the information needed to use BESREMi safely and effectively. See full prescribing information for BESREMi. BESREMI (ropeginterferon alfa-2b-njft) injection, for subcutaneous use Initial U.S. Approval: 202120260326