Edaravone
NDC Package 39822-4500-2

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Edaravone is injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Marketed by Xgen Pharmaceuticals Djb, Inc., this product is identified by NDC 39822-4500 and is authorized under FDA application ANDA217565.

Identification & Billing

NDC Package Code
39822-4500-2
Package Description
2 VIAL, SINGLE-DOSE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-DOSE (39822-4500-1)
Product Code
39822-4500
11-Digit Billing Format
39822450002
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
Dosage Form
-
Usage Information
Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Regulatory & Marketing

Labeler Name
Xgen Pharmaceuticals Djb, Inc.
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
05-31-2026
Listing Expiration
05-31-2026
Exclude Flag
D
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 39822-4500-2 identifies a specific commercial package of 2 vial, single-dose in 1 carton / 100 ml in 1 vial, single-dose (39822-4500-1) of Edaravone, labeled by Xgen Pharmaceuticals Djb, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Xgen Pharmaceuticals Djb, Inc. on December 02, 2024. The current certification is valid through May 31, 2026.

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: 39822450002. 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)
39822-4500-2
11-Digit CMS (5-4-2)
39822-4500-02

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