1. Home
  2. Labeler Index
  3. Sarepta Therapeutics, Inc.
  4. 60923-509
  5. NDC Package Code: 60923-509-18 Elevidys

NDC Package 60923-509-18 Elevidys

Delandistrogene Moxeparvovec-rokl Kit Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
60923-509-18
Package Description:
1 KIT in 1 CARTON * 10 mL in 1 VIAL, SINGLE-USE (60923-562-01) * 18 POUCH in 1 BOX / 1 SWAB in 1 POUCH
Product Code:
60923-509
Proprietary Name:
Elevidys
Non-Proprietary Name:
Delandistrogene Moxeparvovec-rokl
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).
11-Digit NDC Billing Format:
60923050918
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to 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]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sarepta Therapeutics, Inc.
    Dosage Form:
    Kit - A packaged collection of related material.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Sample Package:
    No
    FDA Application Number:
    BLA125781
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    06-22-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 60923-509-18?

    The NDC Packaged Code 60923-509-18 is assigned to a package of 1 kit in 1 carton * 10 ml in 1 vial, single-use (60923-562-01) * 18 pouch in 1 box / 1 swab in 1 pouch of Elevidys, a human prescription drug labeled by Sarepta Therapeutics, Inc.. The product's dosage form is kit and is administered via intravenous form.

    Is NDC 60923-509 included in the NDC Directory?

    Yes, Elevidys with product code 60923-509 is active and included in the NDC Directory. The product was first marketed by Sarepta Therapeutics, Inc. on June 22, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 60923-509-18?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 60923-509-18?

    The 11-digit format is 60923050918. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-260923-509-185-4-260923-0509-18