FDA.reportPublic FDA data

1 ML denosumab-nxxp 60 MG/ML Prefilled Syringe

RxCUI
2723350
RxNorm name
1 ML denosumab-nxxp 60 MG/ML Prefilled Syringe
Display name
1 ML denosumab-nxxp 60 MG/ML Prefilled Syringe
Full name
1 ML denosumab-nxxp 60 MG/ML Prefilled Syringe
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:18

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761444Bildyosdenosumab-nxxp351(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.

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
b9e32bf7-d70a-4083-8577-c15751c7f769denosumab-nxxp 60 MG in 1 ML Prefilled Syringe [PSN] · 1 ML denosumab-nxxp 60 MG/ML Prefilled Syringe [SCD] · denosumab-nxxp 60 MG per 1 ML Prefilled Syringe [SY]32These highlights do not include all the information needed to use BILDYOS safely and effectively. See full prescribing information for BILDYOS. BILDYOS ® (denosumab-nxxp) injection, for subcutaneous use Initial U.S. Approval: 2025 BILDYOS ® (denosumab-nxxp) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betw20250910