JUBBONTI
- Product NDC
- 61314-240
- 11-digit product format
- 613140240
- Labeler code
- 61314
- Product ID
- 61314-240_3f864a08-c693-4fdf-8158-c9e0d956fcad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- denosumab
- Dosage form
- INJECTION
- Route
- SUBCUTANEOUS
- Labeler
- Sandoz Inc
- Application
- BLA761362
- Marketing category
- BLA
- Marketing start
- 2025-06-02
- 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
- JUBBONTI
- 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 | 2715513, 2715520 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61314-240-63 | JUBBONTI | 1 mL in 1 SYRINGE | INJECTION | 1 | | 6 |
| 61314-240-63 | JUBBONTI | 1 in 1 CARTON | INJECTION | 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 |
|---|
| 61314-240-63 | 61314024063 | 1 SYRINGE in 1 CARTON (61314-240-63) / 1 mL in 1 SYRINGE | 1 syringe | 2025-06-02 | No | No | Current |