Prescription drug · NDA
Arranon (Nelarabine) NDC 66758-165
Nelarabine 5 mg/mL · Injection · Intravenous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66758-165-94 | 6675801659466758016594 | 1 VIAL in 1 CARTON (66758-165-94) / 50 mL in 1 VIALMarketed from Sep 5, 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)
- Arranon
- Generic name (nonproprietary)
- nelarabine
- Active ingredients
- Nelarabine — 5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Sandoz IncNDC labeler code 66758
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021877
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 66758-165_0015d51c-784c-4f0d-938c-6c81decd5903SPL ID 0015d51c-784c-4f0d-938c-6c81decd5903SPL set ID 0f9051de-5c4d-4c0f-8c19-e15214498ccaRxCUI 603566, 616366UNII 60158CV180UPC 0366758165942
- Pharmacologic class
- Nucleoside Metabolic 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 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
N466758016594followed by a unit qualifier and the quantityPackage 66758-0165-94. 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)
ARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. ARRANON is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 66758-165
- What is NDC 66758-165?
- 66758-165 is the product NDC for Arranon (nelarabine), Nelarabine 5 mg/mL injection, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Arranon (Nelarabine).
- What is the active ingredient?
- Nelarabine.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 66758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Arranon?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.