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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BILDYOS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DENOSUMAB | 60 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EQZ6YO2HI |
| Rxcui | 2723350, 2723357 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 | Current |