Oziltus
- Product NDC
- 70121-2701
- Requested package NDC
- 70121-2701-1
- 11-digit product format
- 701212701
- Labeler code
- 70121
- Product ID
- 70121-2701_165cbe29-f9fd-492f-a604-0979ed765680
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- denosumab-mobz
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- BLA761457
- Marketing category
- BLA
- Marketing start
- 2025-12-23
- Substance
- DENOSUMAB
- Active strength
- 70 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
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oziltus
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DENOSUMAB | 70 mg/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70121-2701-1 | Oziltus | 1.7 mL in 1 VIAL | INJECTION, SOLUTION | 1.7 | | 4 |
| 70121-2701-1 | Oziltus | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761457 | Oziltus | denosumab-mobz | 351(k) Interchangeable | Rx | 2026-09-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70121-2701-1 | 70121270101 | 1 VIAL in 1 CARTON (70121-2701-1) / 1.7 mL in 1 VIAL | 1 vial | 2025-12-23 | No | No | Current |