Prescription drug · BLA
Bomyntra (denosumab) NDC 65219-670
Denosumab 70 mg/mL · Injection · Subcutaneous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-670-01 | 65219067001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-670-01) / 1.7 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 30, 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)
- Bomyntra
- Generic name (nonproprietary)
- denosumab
- Active ingredients
- Denosumab — 70 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761398
- Marketing start
- Listing expires
- Other FDA classes
- RANK Ligand Blocking Activity (Mechanism)
- Identifiers
- Product ID 65219-670_fd3a3b73-bf8e-4538-9eee-b3d652251260SPL ID fd3a3b73-bf8e-4538-9eee-b3d652251260SPL set ID 49d25732-e05d-47e4-98cb-67df04796d4bRxCUI 2717542, 2717549, 2717551, 2717555UNII 4EQZ6YO2HIUPC 0365219672012, 0365219670018
- 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
N465219067001followed by a unit qualifier and the quantityPackage 65219-0670-01. 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)
Bomyntra 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 Bomyntra 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 Ce…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761398
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Conexxencedenosumab | Denosumab 60 mg/mL | InjectionSubcutaneous | Fresenius Kabi USA, LLC | 65219-668 |
| Bomyntradenosumab | Denosumab 70 mg/mL | InjectionSubcutaneous | Fresenius Kabi USA, LLC | 65219-672 |