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  5. NDC Package Code: 61434-003-01 Eteplirsen

NDC Package 61434-003-01 Eteplirsen

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

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.

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:
61434-003-01
Package Description:
352 VIAL in 1 CASE / 2 mL in 1 VIAL
Product Code:
61434-003
Non-Proprietary Name:
Eteplirsen
Substance Name:
Eteplirsen
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.
11-Digit NDC Billing Format:
61434000301
Product Type:
Human Prescription Drug
Labeler Name:
Catalent Indiana, Llc
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Active Ingredient(s):
  • ETEPLIRSEN 100 mg/2mL
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    09-19-2016
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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 61434-003-01?

    The NDC Packaged Code 61434-003-01 is assigned to an UNFINISHED drug package of 352 vial in 1 case / 2 ml in 1 vial of Eteplirsen, a human prescription drug labeled by Catalent Indiana, Llc. The product's dosage form is injection and is administered via form.

    Is NDC 61434-003 included in the NDC Directory?

    Yes, Eteplirsen is an UNFINISHED PRODUCT with code 61434-003 that is active and included in the NDC Directory. The product was first marketed by Catalent Indiana, Llc on September 19, 2016 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 61434-003-01?

    The 11-digit format is 61434000301. 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
    5-3-261434-003-015-4-261434-0003-01