Prescription drug · NDA
Defitelio (defibrotide sodium) NDC 68727-800
Defibrotide sodium 80 mg/mL · Injection, Solution · Intravenous · Jazz Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68727-800-01 | 68727080001 | 2.5 mL in 1 VIAL (68727-800-01)Marketed from Mar 30, 2016 | |
| 68727-800-02 | 68727080002 | 25 mL in 1 CARTON (68727-800-02)Marketed from Mar 30, 2016 |
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)
- Defitelio
- Generic name (nonproprietary)
- defibrotide sodium
- Active ingredients
- Defibrotide sodium — 80 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Jazz Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208114
- Marketing start
- Listing expires
- Identifiers
- Product ID 68727-800_0269ad44-e351-4411-8866-d8d53e28fb74SPL ID 0269ad44-e351-4411-8866-d8d53e28fb74SPL set ID 2c3db989-d7ad-41ed-9ebf-698dcf6c24ecRxCUI 1746527, 1746532UNII L7CHH2B2J0
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
N468727080001followed by a unit qualifier and the quantityPackage 68727-0800-01. 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 .
Indications (excerpt from the label)
DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). DEFITELIO is indicated for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). ( 1 )
Excerpt only. Read the full label for complete information.