OSPOMYV
- Product NDC
- 83457-012
- 11-digit product format
- 834570012
- Labeler code
- 83457
- Product ID
- 83457-012_701ab9b4-0ad7-4b34-b66f-f75b41d0e1e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- denosumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Cordavis Limited
- Application
- BLA761392
- Marketing category
- BLA
- Marketing start
- 2025-10-10
- 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
- OSPOMYV
- 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 | 2725502, 2725509 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83457-012-10 | OSPOMYV | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 6 |
| 83457-012-10 | OSPOMYV | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83457-012-10 | 83457001210 | 1 SYRINGE in 1 CARTON (83457-012-10) / 1 mL in 1 SYRINGE | 1 syringe | 2025-10-10 | No | No | Historical |