NDC codes

FDA NDC Directory
Product NDC (as listed)83257-030Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83257-0030Add 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 NDC11-digit (billing)PackageCopy
83257-030-11832570030111 VIAL, SINGLE-USE in 1 CARTON (83257-030-11) / 1.7 mL in 1 VIAL, SINGLE-USEMarketed from Jan 5, 2026

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)
Aukelso
Generic name (nonproprietary)
denosumab-kyqq
Active ingredients
Denosumab120 mg/1.7mL
Dosage form
Injection
Route
Subcutaneous
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 761436
Marketing start
Listing expires
Other FDA classes
RANK Ligand Blocking Activity (Mechanism)
Identifiers
Product ID 83257-030_019c406f-d5d0-d9d0-25c1-664d4dc4e776SPL ID 019c406f-d5d0-d9d0-25c1-664d4dc4e776SPL set ID 547cb095-f7f5-f933-75ce-5e6abf2ad5bcRxCUI 2725939, 2725946UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N483257003011 followed by a unit qualifier and the quantity

Package 83257-0030-11. 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)

Aukelso 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 Aukelso 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 761436

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

FDA NDC Directory listings under BLA 761436
ProductStrengthForm · routeLabelerProduct NDC
Bosayadenosumab-kyqqDenosumab 60 mg/mLInjectionSubcutaneousBiocon Biologics Inc.83257-029

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