Denosumab-BMWO
- Product NDC
- 72606-058
- 11-digit product format
- 726060058
- Labeler code
- 72606
- Product ID
- 72606-058_180d317f-8fa9-4e03-bc3e-756bcfbb4fd6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- denosumab-bmwo
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- CELLTRION USA, Inc.
- Application
- BLA761404
- Marketing category
- BLA
- Marketing start
- 2025-09-10
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Denosumab-BMWO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DENOSUMAB | 60 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4EQZ6YO2HI |
| Rxcui | 2717855 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72606-058-01 | Denosumab-BMWO | 1 in 1 CARTON | INJECTION | 1 | | 4 |
| 72606-058-01 | Denosumab-BMWO | 1 mL in 1 SYRINGE | INJECTION | 1 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72606-058-01 | 72606005801 | 1 SYRINGE in 1 CARTON (72606-058-01) / 1 mL in 1 SYRINGE | 1 syringe | 2025-09-10 | No | No | Historical |