Prescription drug · BLA
Prolia (denosumab) NDC 55513-710
Denosumab 60 mg/mL · Injection · Subcutaneous · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-710-01 | 55513071001 | 1 SYRINGE in 1 CARTON (55513-710-01) / 1 mL in 1 SYRINGEMarketed from Jun 5, 2010 | |
| 55513-710-21 | 55513071021 | 1 SYRINGE in 1 CARTON (55513-710-21) / 1 mL in 1 SYRINGEMarketed from Mar 5, 2024 |
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)
- Prolia
- Generic name (nonproprietary)
- denosumab
- Active ingredients
- Denosumab — 60 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Amgen, Inc
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125320
- Marketing start
- Listing expires
- Other FDA classes
- RANK Ligand Blocking Activity (Mechanism)
- Identifiers
- Product ID 55513-710_f7182c92-ea87-4fec-b8f1-d8860f872b60SPL ID f7182c92-ea87-4fec-b8f1-d8860f872b60SPL set ID 49e5afe9-a0c7-40c4-af9f-f287a80c5c88RxCUI 993452, 993456UNII 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.
- 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
N455513071001followed by a unit qualifier and the quantityPackage 55513-0710-01. 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)
Prolia 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 Prolia is indicated for the treatment …
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125320
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 |
|---|---|---|---|---|
| Xgevadenosumab | Denosumab 120 mg/1.7mL | InjectionSubcutaneous | Amgen, Inc | 55513-730 |