FDA.reportPublic FDA data

1 ML denosumab-mobz 60 MG/ML Prefilled Syringe [Boncresa]

RxCUI
2729319
RxNorm name
1 ML denosumab-mobz 60 MG/ML Prefilled Syringe [Boncresa]
Display name
1 ML denosumab-mobz 60 MG/ML Prefilled Syringe [Boncresa]
Full name
1 ML denosumab-mobz 60 MG/ML Prefilled Syringe [Boncresa]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:38:51

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761456Boncresadenosumab-mobz351(k) InterchangeableRx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

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
29140df2-24a3-4a6f-a8e3-065521448d61Boncresa 60 MG in 1 ML Prefilled Syringe [PSN] · 1 ML denosumab-mobz 60 MG/ML Prefilled Syringe [Boncresa] [SBD] · Boncresa 60 MG per 1 ML Prefilled Syringe [SY] · Boncresa 60 MG/ML per 1 ML Prefilled Syringe [SY]45These highlights do not include all the information needed to use BONCRESA safely and effectively. See full prescribing information for BONCRESA. BONCRESA ® (denosumab-mobz) injection, for subcutaneous use Initial U.S. Approval: 2010 BONCRESA (denosumab-mobz) is biosimilar* to PROLIA ® (denosumab)20251222