Avi-4658 Powder
NDC Package 52416-130-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Avi-4658 powders is eteplirsen is used to treat a certain inherited muscle disorder (Duchenne muscular dystrophy-DMD). This formulation utilizes a powder delivery system. Marketed by Bachem Americas, Inc., this product is identified by NDC 52416-130.

Identification & Billing

NDC Package Code
52416-130-01
Package Description
1 g in 1 BAG
Product Code
52416-130
11-Digit Billing Format
52416013001

Clinical Specifications

Proprietary Name
Avi-4658
Non-Proprietary Name
Avi-4658
Substance Name
Eteplirsen
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
ETEPLIRSEN 1 g/g
Usage Information
Eteplirsen is used to treat a certain inherited muscle disorder (Duchenne muscular dystrophy-DMD). This disorder is caused by a lack of a certain muscle protein (dystrophin). This medication can increase the amount of dystrophin in your body.

Regulatory & Marketing

Labeler Name
Bachem Americas, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
02-18-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 52416-130-01 identifies a specific commercial package of 1 g in 1 bag of Avi-4658 (UNFINISHED drug), a bulk ingredient labeled by Bachem Americas, Inc.. This powder is formulated for use and contains eteplirsen 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 Bachem Americas, Inc. on February 18, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Eteplirsen is used to treat a certain inherited muscle disorder (Duchenne muscular dystrophy-DMD). This disorder is caused by a lack of a certain muscle protein (dystrophin). This medication can increase the amount of dystrophin in your body.

How is this Bachem Americas, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52416013001. 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)
52416-130-01
11-Digit CMS (5-4-2)
52416-0130-01

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