Radicava Ors Kit
NDC Package 70510-2321-2

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

Package Information

Radicava Ors (edaravone) kits 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 kit delivery system. Marketed by Shionogi Inc., this product is identified by NDC 70510-2321 and is authorized under FDA application NDA215446.

Identification & Billing

NDC Package Code
70510-2321-2
Package Description
2 CARTON in 1 CARTON / 1 KIT in 1 CARTON (70510-2321-1) * 1 BOTTLE in 1 KIT (70510-2323-1) / 35 mL in 1 BOTTLE
Product Code
70510-2321
11-Digit Billing Format
70510232102
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Radicava Ors
Non-Proprietary Name
Edaravone
Dosage Form
Kit - A packaged collection of related material.
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
Shionogi Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215446
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-12-2022
Listing Expiration
12-31-2027
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 70510-2321-2 identifies a specific commercial package of 2 carton in 1 carton / 1 kit in 1 carton (70510-2321-1) * 1 bottle in 1 kit (70510-2323-1) / 35 ml in 1 bottle of Radicava Ors, a human prescription drug labeled by Shionogi Inc.. This kit is formulated for use and contains 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 Shionogi Inc. on May 12, 2022. The current certification is valid through December 31, 2027.

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 Shionogi Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70510232102. 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)
70510-2321-2
11-Digit CMS (5-4-2)
70510-2321-02

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