Prescription drug · BLA
Oziltus (denosumab-mobz) NDC 70121-2701
Denosumab 70 mg/mL · Injection, Solution · Subcutaneous · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70121-2701-1 | 70121270101 | 1 VIAL in 1 CARTON (70121-2701-1) / 1.7 mL in 1 VIALMarketed from Dec 23, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Oziltus
- Generic name (nonproprietary)
- denosumab-mobz
- Active ingredients
- Denosumab — 70 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Amneal Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761457
- Marketing start
- Listing expires
- Other FDA classes
- RANK Ligand Blocking Activity (Mechanism)
- Identifiers
- Product ID 70121-2701_b34597a1-251b-4c4b-9457-c3de26d5c26eSPL ID b34597a1-251b-4c4b-9457-c3de26d5c26eSPL set ID f040a245-1be4-4962-a8b7-a13ee7fac707RxCUI 2729323, 2729330UNII 4EQZ6YO2HIUPC 0370121270119
- Pharmacologic class
- RANK Ligand Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeMed-Code curated
J0897 — Injection, denosumab, 1 mg
Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.
Denosumab biosimilars have their own HCPCS codes.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470121270101followed by a unit qualifier and the quantityPackage 70121-2701-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Oziltus is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. ( 1.1 ) Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Oziltus is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell…
Excerpt only. Read the full label for complete information.