1 ML denosumab-dssb 60 MG/ML Prefilled Syringe [Ospomyv]
- RxCUI
- 2725509
- RxNorm name
- 1 ML denosumab-dssb 60 MG/ML Prefilled Syringe [Ospomyv]
- Display name
- 1 ML denosumab-dssb 60 MG/ML Prefilled Syringe [Ospomyv]
- Full name
- 1 ML denosumab-dssb 60 MG/ML Prefilled Syringe [Ospomyv]
- Term type
- SBD
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:25
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761392 | Ospomyv | denosumab-dssb | 351(k) Interchangeable | Rx | 2026-07-01 |
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 |
|---|---|---|---|---|---|---|
| OSPOMYV | DENOSUMAB | Cordavis Limited | e1d80a82-de52-4a34-9df3-609e50667ffb | 2025-11-11 | Boxed warning, Warnings, Adverse reactions | 2725509 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| e1d80a82-de52-4a34-9df3-609e50667ffb | OSPOMYV 60 MG in 1 ML Prefilled Syringe [PSN] · 1 ML denosumab-dssb 60 MG/ML Prefilled Syringe [Ospomyv] [SBD] · 1 ML Ospomyv 60 MG/ML Prefilled Syringe [SY] · Ospomyv 60 MG per 1 ML Prefilled Syringe [SY] | 4 | 6 | These highlights do not include all the information needed to use OSPOMYV safely and effectively. See full prescribing information for OSPOMYV. OSPOMYV™ (denosumab-dssb) injection, for subcutaneous use Initial U.S. Approval: 2025 OSPOMYV (denosumab-dssb) 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 | 20251111 |