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  5. NDC Package Code: 53296-0127-0 Revefenacin

NDC Package 53296-0127-0 Revefenacin

Powder - 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:
53296-0127-0
Package Description:
75 kg in 1 DRUM
Product Code:
53296-0127
Non-Proprietary Name:
Revefenacin
Substance Name:
Revefenacin
Usage Information:
Revefenacin is a long-term medication used to treat an ongoing lung disease, chronic obstructive pulmonary disease (COPD). It must be used regularly to reduce and prevent symptoms such as shortness of breath, cough, and wheezing. This medication belongs to a class of drugs known as anticholinergics. It works by relaxing the muscles around the airways so that they open up and you can breathe more easily. Revefenacin does not work right away and should not be used to relieve sudden breathing problems. If wheezing or sudden shortness of breath occurs, use your quick-relief inhaler as prescribed.
11-Digit NDC Billing Format:
53296012700
Product Type:
Bulk Ingredient
Labeler Name:
Medichem S.a.
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
  • REVEFENACIN 75 kg/75kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    11-18-2020
    Listing Expiration Date:
    12-31-2024
    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 53296-0127-0?

    The NDC Packaged Code 53296-0127-0 is assigned to an UNFINISHED drug package of 75 kg in 1 drum of Revefenacin, a bulk ingredient labeled by Medichem S.a.. The product's dosage form is powder and is administered via form.

    Is NDC 53296-0127 included in the NDC Directory?

    Yes, Revefenacin is an UNFINISHED PRODUCT with code 53296-0127 that is active and included in the NDC Directory. The product was first marketed by Medichem S.a. on November 18, 2020 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 11-digit format for NDC 53296-0127-0?

    The 11-digit format is 53296012700. 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 5-4-1 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
    5-4-153296-0127-05-4-253296-0127-00