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 | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761404 | Stoboclo | denosumab-bmwo | 351(k) Interchangeable | Rx | 2026-06-01 |
UNII Substances#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Denosumab-BMWO | DENOSUMAB-BMWO | CELLTRION USA, Inc. | 7a449553-105c-46a1-bb72-849d8f5b81bd | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 2717855 |
| Stoboclo | DENOSUMAB-BMWO | CELLTRION USA, Inc. | 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 2717855 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm string | TTY | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | denosumab-bmwo 60 MG per 1 ML Prefilled Syringe | SY | 7 | These 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 |
| 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | 1 ML denosumab-bmwo 60 MG/ML Prefilled Syringe | SCD | 7 | These 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 |
| 10b9eea3-bf70-4ff3-a0b9-54248cbfd156 | denosumab-bmwo 60 MG in 1 ML Prefilled Syringe | PSN | 7 | These 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-bb72-849d8f5b81bd | denosumab-bmwo 60 MG in 1 ML Prefilled Syringe | PSN | 4 | These 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 bi | 20260205 |
| 7a449553-105c-46a1-bb72-849d8f5b81bd | denosumab-bmwo 60 MG per 1 ML Prefilled Syringe | SY | 4 | These 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 bi | 20260205 |
| 7a449553-105c-46a1-bb72-849d8f5b81bd | 1 ML denosumab-bmwo 60 MG/ML Prefilled Syringe | SCD | 4 | These 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 bi | 20260205 |