Exondys 51 Injection
NDC Package 60923-284-10

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

Package Information

Exondys 51 (eteplirsen) injection is eteplirsen is used to treat a certain inherited muscle disorder (Duchenne muscular dystrophy-DMD). This formulation utilizes a injection delivery system. Marketed by Sarepta Therapeutics, Inc., this product is identified by NDC 60923-284 and is authorized under FDA application NDA206488.

Identification & Billing

NDC Package Code
60923-284-10
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-USE
Product Code
60923-284
11-Digit Billing Format
60923028410
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Exondys 51
Non-Proprietary Name
Eteplirsen
Substance Name
Eteplirsen
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ETEPLIRSEN 50 mg/mL
Pharmacologic Class
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
Sarepta Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA206488
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-19-2016
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1428
Source: OPPS
Inj, eteplirsen, 10 mg
HCPCS Dosage 10 MG
Units / Pkg 50

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 60923-284-10 identifies a specific commercial package of 1 vial, single-use in 1 carton / 10 ml in 1 vial, single-use of Exondys 51, a human prescription drug labeled by Sarepta Therapeutics, Inc.. This injection is formulated for intravenous 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 Sarepta Therapeutics, Inc. on September 19, 2016. 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 Sarepta Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60923028410. 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 (5-3-2)
60923-284-10
11-Digit CMS (5-4-2)
60923-0284-10

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