Xgeva (denosumab) NDC 55513-730 · J-Code J0897

NDC codes

FDA NDC Directory

Product NDC (as listed)55513-730Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55513-0730Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
55513-730-01	55513073001	1 VIAL, SINGLE-USE in 1 CARTON (55513-730-01) / 1.7 mL in 1 VIAL, SINGLE-USEMarketed from Nov 18, 2010
55513-730-21	55513073021	1 VIAL, SINGLE-USE in 1 CARTON (55513-730-21) / 1.7 mL in 1 VIAL, SINGLE-USEMarketed from Apr 15, 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): Xgeva
Generic name (nonproprietary): denosumab
Active ingredients: Denosumab — 120 mg/1.7mL
Dosage form: Injection
Route: Subcutaneous
Labeler: Amgen, Inc
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125320
Marketing start: Nov 18, 2010
Listing expires: Dec 31, 2027
Other FDA classes: RANK Ligand Blocking Activity (Mechanism)
Identifiers: Product ID 55513-730_3ce47aaf-105d-4615-9320-1f378a9d8d84SPL ID 3ce47aaf-105d-4615-9320-1f378a9d8d84SPL set ID 628f0998-1206-4001-aeee-18133aa9f3bfRxCUI 1046398, 1046402UNII 4EQZ6YO2HIUPC 0355513730013
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.

How CPT relates to drug billing

NDC on a medical claim

N455513073001 followed by a unit qualifier and the quantity

Package 55513-0730-01. 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 Jun 23, 2026.

Indications (excerpt from the label)

Xgeva 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 Xgeva 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 Tum…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 125320

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 125320
Product	Strength	Form · route	Labeler	Product NDC
Proliadenosumab	Denosumab 60 mg/mL	InjectionSubcutaneous	Amgen, Inc	55513-710