Prescription drug · BLA
Denosumab-BMWO NDC 72606-058
Denosumab 60 mg/mL · Injection · Subcutaneous · CELLTRION USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72606-058-01 | 72606005801 | 1 SYRINGE in 1 CARTON (72606-058-01) / 1 mL in 1 SYRINGEMarketed from Sep 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)
- Denosumab-BMWO
- Generic name (nonproprietary)
- denosumab-bmwo
- Active ingredients
- Denosumab — 60 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- CELLTRION USA, Inc.NDC labeler code 72606
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761404
- Marketing start
- Listing expires
- Other FDA classes
- RANK Ligand Blocking Activity (Mechanism)
- Identifiers
- Product ID 72606-058_180d317f-8fa9-4e03-bc3e-756bcfbb4fd6SPL ID 180d317f-8fa9-4e03-bc3e-756bcfbb4fd6SPL set ID 7a449553-105c-46a1-bb72-849d8f5b81bdRxCUI 2717855UNII 4EQZ6YO2HIUPC 0372606058014
- 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
N472606005801followed by a unit qualifier and the quantityPackage 72606-0058-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Denosumab-bmwo 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 Denosumab-bmwo is indicated fo…
Excerpt only. Read the full label for complete information.
About NDC 72606-058
- What is NDC 72606-058?
- 72606-058 is the product NDC for Denosumab-BMWO, Denosumab 60 mg/mL injection, listed with the FDA by CELLTRION USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Denosumab-BMWO.
- What is the active ingredient?
- Denosumab.
- Who is the labeler?
- CELLTRION USA, Inc., NDC labeler code 72606. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Denosumab-BMWO?
- 1 other product NDC are listed under this name. See all Denosumab-BMWO NDCs.
- Is there a related HCPCS / J-code?
- Yes: J0897, Injection, denosumab, 1 mg. See Billing references above.
Related NDCs: other Denosumab-BMWO products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Denosumab-BMWO | Denosumab 120 mg/1.7mL | InjectionSubcutaneous | CELLTRION USA, Inc. | 72606-059 | 72606-0059-01 |
Other NDCs under BLA 761404
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 |
|---|---|---|---|---|
| Denosumab-BMWO | Denosumab 120 mg/1.7mL | InjectionSubcutaneous | CELLTRION USA, Inc. | 72606-059 |
| Osenveltdenosumab-bmwo | Denosumab 120 mg/1.7mL | InjectionSubcutaneous | CELLTRION USA, Inc. | 72606-038 |
| Stoboclodenosumab-bmwo | Denosumab 60 mg/mL | InjectionSubcutaneous | CELLTRION USA, Inc. | 72606-037 |