Elevidys Kit
NDC Package 60923-511-20

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

Elevidys (delandistrogene moxeparvovec-rokl) kits is eLEVIDYS is indicated for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. This formulation utilizes a kit delivery system. Marketed by Sarepta Therapeutics, Inc., this product is identified by NDC 60923-511 and is authorized under FDA application BLA125781.

Identification & Billing

NDC Package Code
60923-511-20
Package Description
1 KIT in 1 CARTON * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 20 POUCH in 1 BOX / 1 SWAB in 1 POUCH
Product Code
60923-511
11-Digit Billing Format
60923051120
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
  • RxCUI: 2641679 - delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES in 10 ML Injection
  • RxCUI: 2641679 - 10 ML delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES/ML Injection
  • RxCUI: 2641679 - delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES per 10 ML Injection
  • RxCUI: 2641685 - ELEVIDYS 13300000000000 VECTOR-GENOMES in 10 ML Injection
  • RxCUI: 2641685 - 10 ML delandistrogene moxeparvovec-rokl 13300000000000 VECTOR-GENOMES/ML Injection [Elevidys]

Clinical Specifications

Proprietary Name
Elevidys
Non-Proprietary Name
Delandistrogene Moxeparvovec-rokl
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Intravenous - Administration within or into a vein or veins.
Usage Information
ELEVIDYS is indicated for the treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. This indication is approved under accelerated approval based on expression of ELEVIDYS micro-dystrophin observed in patients treated with ELEVIDYS [see Clinical Pharmacology (12), Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Sarepta Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125781
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-22-2023
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.

J1413
Source: OPPS
Inj delandistrogene mox rokl
HCPCS Dosage Per Therapeutic Dose
Units / Pkg 1

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 60923-511-20 identifies a specific commercial package of 1 kit in 1 carton * 10 ml in 1 vial, single-use (60923-562-01) * 20 pouch in 1 box / 1 swab in 1 pouch of Elevidys, a human prescription drug labeled by Sarepta Therapeutics, Inc.. This kit is formulated for intravenous 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 Sarepta Therapeutics, Inc. on June 22, 2023. The current certification is valid through December 31, 2026.

How is this Sarepta Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60923051120. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
60923-511-20
11-Digit CMS (5-4-2)
60923-0511-20

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