FDA.reportPublic FDA data

BESREMi 500 MCG in 1 ML Prefilled Syringe

RxCUI
2587070
RxNorm name
BESREMi 500 MCG in 1 ML Prefilled Syringe
Display name
BESREMi 500 MCG in 1 ML Prefilled Syringe
Full name
BESREMi 500 MCG in 1 ML Prefilled Syringe
Term type
PSN
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)Rx2026-06-01

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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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-5e6384ebabcb2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2587070

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
9583405d-53a0-49dc-88eb-5e6384ebabcbBESREMi 500 MCG in 1 ML Prefilled SyringePSN11These 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
9583405d-53a0-49dc-88eb-5e6384ebabcb1 ML ropeginterferon alfa-2b-njft 0.5 MG/ML Prefilled Syringe [Besremi]SBD11These 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
9583405d-53a0-49dc-88eb-5e6384ebabcbBesremi 500 MCG per 1 ML Prefilled SyringeSY11These 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