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  5. NDC Package Code: 60923-465-02 Vyondys 53

NDC Package 60923-465-02 Vyondys 53

Golodirsen Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. 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:
60923-465-02
Package Description:
1 VIAL, SINGLE-USE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-USE
Product Code:
60923-465
Proprietary Name:
Vyondys 53
Non-Proprietary Name:
Golodirsen
Substance Name:
Golodirsen
Usage Information:
VYONDYS 53 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53 [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
11-Digit NDC Billing Format:
60923046502
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2267211 - golodirsen 100 MG in 2 ML Injection
  • RxCUI: 2267211 - 2 ML golodirsen 50 MG/ML Injection
  • RxCUI: 2267211 - golodirsen 100 MG per 2 ML Injection
  • RxCUI: 2267216 - VYONDYS 53 Injection 100 MG in 2 ML
  • RxCUI: 2267216 - 2 ML golodirsen 50 MG/ML Injection [Vyondys 53]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sarepta Therapeutics, Inc.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • GOLODIRSEN 50 mg/mL
    • Sample Package:
    No
    FDA Application Number:
    NDA211970
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-12-2019
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 60923-465-02 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    60923046502J1429Inj golodirsen 10 mg10 MG211010

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 60923-465-02?

    The NDC Packaged Code 60923-465-02 is assigned to a package of 1 vial, single-use in 1 carton / 2 ml in 1 vial, single-use of Vyondys 53, a human prescription drug labeled by Sarepta Therapeutics, Inc.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 60923-465 included in the NDC Directory?

    Yes, Vyondys 53 with product code 60923-465 is active and included in the NDC Directory. The product was first marketed by Sarepta Therapeutics, Inc. on December 12, 2019 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 60923-465-02?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 60923-465-02?

    The 11-digit format is 60923046502. 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
    5-3-260923-465-025-4-260923-0465-02