BILDYOS 60 MG in 1 ML Prefilled Syringe
- RxCUI
- 2723357
- RxNorm name
- BILDYOS 60 MG in 1 ML Prefilled Syringe
- Display name
- BILDYOS 60 MG in 1 ML Prefilled Syringe
- Full name
- BILDYOS 60 MG in 1 ML Prefilled Syringe
- Term type
- PSN
- Status
- DailyMed mapping
- Updated
- 2026-06-04 23:39:18
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761444 | Bildyos | denosumab-nxxp | 351(k) Interchangeable | Rx | 2026-08-01 |
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 |
|---|---|---|---|---|---|---|
| BILDYOS | DENOSUMAB | Organon LLC | b9e32bf7-d70a-4083-8577-c15751c7f769 | 2026-08-18 | Boxed warning, Warnings, Adverse reactions | 2723357 |
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| b9e32bf7-d70a-4083-8577-c15751c7f769 | BILDYOS 60 MG in 1 ML Prefilled Syringe [PSN] · 1 ML denosumab-nxxp 60 MG/ML Prefilled Syringe [Bildyos] [SBD] · Bildyos 60 MG per 1 ML Prefilled Syringe [SY] | 3 | 2 | These 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 betw | 20250910 |