BILDYOS
- Product NDC
- 78206-193
- 11-digit product format
- 782060193
- Labeler code
- 78206
- Product ID
- 78206-193_3e7e35c0-50a6-0266-e063-6394a90a3736
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Denosumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Organon LLC
- Application
- BLA761444
- Marketing category
- BLA
- Marketing start
- 2025-09-11
- Substance
- DENOSUMAB
- Active strength
- 60 mg/mL
- Pharmacologic classes
- RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 78206-193 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 78206-193 | 78206-193-01 | I | Inactivated by FDA | 2026-08-17 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| 31f7a69c-73ae-42bf-97ee-e31040596ed6 | Product name | 1 | 20180423 |
| b45e2e3f-1908-4144-8fa5-6f481dea7435 | Product name | 1 | 20170721 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78206-193-01 | BILDYOS | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | 2 | |
| 78206-193-01 | BILDYOS | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 78206-193-01 | ML - Milliliter | 78206-193 | 041e8a0a-4c71-49d0-8136-df284c8f0776 | 1 | 2025-10-14 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761444 | Bildyos | denosumab-nxxp | 351(k) Interchangeable | Rx | 2026-07-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2723357 | BILDYOS 60 MG in 1 ML Prefilled Syringe | PSN | b9e32bf7-d70a-4083-8577-c15751c7f769 | 2 |
| 2723350 | denosumab-nxxp 60 MG in 1 ML Prefilled Syringe | PSN | b9e32bf7-d70a-4083-8577-c15751c7f769 | 2 |
| 2723357 | 1 ML denosumab-nxxp 60 MG/ML Prefilled Syringe [Bildyos] | SBD | b9e32bf7-d70a-4083-8577-c15751c7f769 | 2 |
| 2723350 | 1 ML denosumab-nxxp 60 MG/ML Prefilled Syringe | SCD | b9e32bf7-d70a-4083-8577-c15751c7f769 | 2 |
| 2723357 | Bildyos 60 MG per 1 ML Prefilled Syringe | SY | b9e32bf7-d70a-4083-8577-c15751c7f769 | 2 |
| 2723350 | denosumab-nxxp 60 MG per 1 ML Prefilled Syringe | SY | b9e32bf7-d70a-4083-8577-c15751c7f769 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 78206-193-01 | 78206019301 | 1 SYRINGE, GLASS in 1 CARTON (78206-193-01) / 1 mL in 1 SYRINGE, GLASS | 2025-09-11 | No | No | Historical |