Prescription drug · BLA
Ospomyv (denosumab) NDC 83457-012
Denosumab 60 mg/mL · Injection, Solution · Subcutaneous · Cordavis Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83457-012-10 | 83457001210 | 1 SYRINGE in 1 CARTON (83457-012-10) / 1 mL in 1 SYRINGEMarketed from Oct 10, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Ospomyv
- Generic name (nonproprietary)
- denosumab
- Active ingredients
- Denosumab — 60 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Cordavis Limited
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761392
- Marketing start
- Listing expires
- Other FDA classes
- RANK Ligand Blocking Activity (Mechanism)
- Identifiers
- Product ID 83457-012_701ab9b4-0ad7-4b34-b66f-f75b41d0e1e9SPL ID 701ab9b4-0ad7-4b34-b66f-f75b41d0e1e9SPL set ID e1d80a82-de52-4a34-9df3-609e50667ffbRxCUI 2725502, 2725509UNII 4EQZ6YO2HI
- 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
N483457001210followed by a unit qualifier and the quantityPackage 83457-0012-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Ospomyv is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer ( 1.4 ) to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer ( 1.5 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Ospomyv is indicated for the treatmen…
Excerpt only. Read the full label for complete information.