Prescription drug · BLA
Danyelza (naxitamab) NDC 50633-230
Naxitamab 40 mg/10mL · Injection · Intravenous · BTG International Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50633-230-01 | 50633023001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50633-230-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 1, 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)
- Danyelza
- Generic name (nonproprietary)
- naxitamab
- Active ingredients
- Naxitamab — 40 mg/10mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- BTG International Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761171
- Marketing start
- Listing expires
- Other FDA classes
- Glycolipid Disialoganglioside-directed Antibody Interactions (Mechanism)
- Identifiers
- Product ID 50633-230_5878035d-081a-1653-e063-6394a90af965SPL ID 5878035d-081a-1653-e063-6394a90af965SPL set ID b0f5ee96-369f-4cb9-a783-3bfa70fe8f90RxCUI 2474239, 2474244UNII 9K8GNJ2874
- Pharmacologic class
- Glycolipid Disialoganglioside-directed Antibody
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 codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- 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
N450633023001followed by a unit qualifier and the quantityPackage 50633-0230-01. 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)
DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). DANYELZA is a GD2-binding monoclonal antibody indicated, in c…
Excerpt only. Read the full label for complete information.