FDA.reportPublic FDA data

1 ML denosumab-bmwo 60 MG/ML Prefilled Syringe [Stoboclo]

RxCUI
2717862
RxNorm name
1 ML denosumab-bmwo 60 MG/ML Prefilled Syringe [Stoboclo]
Display name
1 ML denosumab-bmwo 60 MG/ML Prefilled Syringe [Stoboclo]
Full name
1 ML denosumab-bmwo 60 MG/ML Prefilled Syringe [Stoboclo]
Term type
SBD
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StobocloDENOSUMAB-BMWOCELLTRION USA, Inc.10b9eea3-bf70-4ff3-a0b9-54248cbfd1562026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2717862

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
10b9eea3-bf70-4ff3-a0b9-54248cbfd156Stoboclo 60 MG in 1 ML Prefilled Syringe [PSN] · 1 ML denosumab-bmwo 60 MG/ML Prefilled Syringe [Stoboclo] [SBD] · 1 ML Stoboclo 60 MG/ML Prefilled Syringe [SY] · Stoboclo 60 MG per 1 ML Prefilled Syringe [SY]47These 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