What is NDC 66302-014?

66302-014 is the product NDC for Unituxin (dinutuximab), Dinutuximab 3.5 mg/mL injection, listed with the FDA by United Therapeutics Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.

United Therapeutics Corporation, NDC labeler code 66302. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Unituxin?

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.

Unituxin NDC 66302-014 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)66302-014Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66302-0014Add 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
66302-014-01	66302001401	1 VIAL, SINGLE-DOSE in 1 BOX (66302-014-01) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 10, 2015

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): Unituxin
Generic name (nonproprietary): dinutuximab
Active ingredients: Dinutuximab — 3.5 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: United Therapeutics CorporationNDC labeler code 66302
Product type: Prescription drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 125516
Marketing start: Mar 10, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Glycolipid Disialoganglioside-directed Antibody Interactions (Mechanism)
Identifiers: Product ID 66302-014_27169364-7492-47e7-b2f5-7dc7d20e36a7SPL ID 27169364-7492-47e7-b2f5-7dc7d20e36a7SPL set ID d66bdf0d-9d65-45de-ae5b-a58617c27492RxCUI 1606278, 1606283UNII 7SQY4ZUD30
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.

How CPT relates to drug billing

NDC on a medical claim

N466302001401 followed by a unit qualifier and the quantity

Package 66302-0014-01. 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 Jul 6, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Unituxin (dinutuximab) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy [see Clinical Studies (14) ] . Unituxin is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 66302-014

What is NDC 66302-014?: 66302-014 is the product NDC for Unituxin (dinutuximab), Dinutuximab 3.5 mg/mL injection, listed with the FDA by United Therapeutics Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Unituxin (Dinutuximab).
What is the active ingredient?: Dinutuximab.
Who is the labeler?: United Therapeutics Corporation, NDC labeler code 66302. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Unituxin?: 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.

Unituxin (Dinutuximab) NDC 66302-014