Defitelio Injection, Solution
NDC Package 68727-800-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Defitelio (defibrotide sodium) injection is 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). This formulation utilizes a injection, solution delivery system. Marketed by Jazz Pharmaceuticals, Inc., this product is identified by NDC 68727-800 and is authorized under FDA application NDA208114.

Identification & Billing

NDC Package Code
68727-800-01
Package Description
2.5 mL in 1 VIAL
Product Code
68727-800
11-Digit Billing Format
68727080001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
2.5 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Defitelio
Non-Proprietary Name
Defibrotide Sodium
Substance Name
Defibrotide Sodium
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
DEFIBROTIDE SODIUM 80 mg/mL
Usage Information
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).

Regulatory & Marketing

Labeler Name
Jazz Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208114
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-30-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68727-800). Click a package code to view its specific billing and regulatory data.

68727-800-02
25 mL in 1 CARTON

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68727-800-01 identifies a specific commercial package of 2.5 ml in 1 vial of Defitelio, a human prescription drug labeled by Jazz Pharmaceuticals, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 2.5 billable units per package. This injection, solution is formulated for intravenous use and contains defibrotide sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Jazz Pharmaceuticals, Inc. on March 30, 2016. The current certification is valid through December 31, 2026.

How is this Jazz Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68727080001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 2.5 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
68727-800-01
11-Digit CMS (5-4-2)
68727-0800-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.