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) InterchangeableRx2026-07-01

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
BoncresaDENOSUMAB-MOBZAmneal Pharmaceuticals LLC29140df2-24a3-4a6f-a8e3-065521448d612025-12-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2729319

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