FDA.reportPublic FDA data

denosumab-bmwo 60 MG per 1 ML Prefilled Syringe

RxCUI
2717855
RxNorm name
denosumab-bmwo 60 MG per 1 ML Prefilled Syringe
Display name
denosumab-bmwo 60 MG per 1 ML Prefilled Syringe
Full name
denosumab-bmwo 60 MG per 1 ML Prefilled Syringe
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761404Stoboclodenosumab-bmwo351(k) InterchangeableRx2026-08-01

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Denosumab-BMWODENOSUMAB-BMWOCELLTRION USA, Inc.7a449553-105c-46a1-bb72-849d8f5b81bd2026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2717855
StobocloDENOSUMAB-BMWOCELLTRION USA, Inc.10b9eea3-bf70-4ff3-a0b9-54248cbfd1562026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2717855

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
10b9eea3-bf70-4ff3-a0b9-54248cbfd156denosumab-bmwo 60 MG in 1 ML Prefilled Syringe [PSN] · 1 ML denosumab-bmwo 60 MG/ML Prefilled Syringe [SCD] · denosumab-bmwo 60 MG per 1 ML Prefilled Syringe [SY]37These highlights do not include all the information needed to use STOBOCLO safely and effectively. See full prescribing information for STOBOCLO. STOBOCLO ® (denosumab-bmwo) injection, for subcutaneous use Initial U.S. Approval: 2025 STOBOCLO ® (denosumab-bmwo) 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 20260205
7a449553-105c-46a1-bb72-849d8f5b81bddenosumab-bmwo 60 MG in 1 ML Prefilled Syringe [PSN] · 1 ML denosumab-bmwo 60 MG/ML Prefilled Syringe [SCD] · denosumab-bmwo 60 MG per 1 ML Prefilled Syringe [SY]34These highlights do not include all the information needed to use DENOSUMAB-BMWO safely and effectively. See full prescribing information for DENOSUMAB-BMWO. DENOSUMAB-BMWO injection, for subcutaneous use Initial U.S. Approval: 2025 Denosumab-bmwo 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 between the bi20260205