Edaravone Injection, Solution
NDC Package 39822-4510-1

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Edaravone injection is edaravone is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). This formulation utilizes a injection, solution delivery system. Marketed by Xgen Pharmaceuticals Djb, Inc., this product is identified by NDC 39822-4510 and is authorized under FDA application ANDA217565.

Identification & Billing

NDC Package Code
39822-4510-1
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-DOSE
Product Code
39822-4510
11-Digit Billing Format
39822451001
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Edaravone
Non-Proprietary Name
Edaravone
Substance Name
Edaravone
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)
EDARAVONE 60 mg/100mL
Usage Information
Edaravone is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). It helps to slow down the worsening of this disease. However, it is not a cure for ALS, and it does not reverse nerve damage or muscle weakness.

Regulatory & Marketing

Labeler Name
Xgen Pharmaceuticals Djb, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217565
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-02-2024
End Marketing Date
09-30-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 39822-4510-1 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 100 ml in 1 vial, single-dose of Edaravone, a human prescription drug labeled by Xgen Pharmaceuticals Djb, Inc.. This injection, solution is formulated for intravenous use and contains edaravone 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 Xgen Pharmaceuticals Djb, Inc. on December 02, 2024.

What are the primary indications for this medication?

Edaravone is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). It helps to slow down the worsening of this disease. However, it is not a cure for ALS, and it does not reverse nerve damage or muscle weakness.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 39822451001. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (5-4-1)
39822-4510-1
11-Digit CMS (5-4-2)
39822-4510-01

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