Revefenacin Powder
NDC Package 53296-0127-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Revefenacin powders is revefenacin is a long-term medication used to treat an ongoing lung disease, chronic obstructive pulmonary disease (COPD). This formulation utilizes a powder delivery system. Marketed by Medichem S.a., this product is identified by NDC 53296-0127.

Identification & Billing

NDC Package Code
53296-0127-0
Package Description
75 kg in 1 DRUM
Product Code
53296-0127
11-Digit Billing Format
53296012700

Clinical Specifications

Proprietary Name
Revefenacin
Non-Proprietary Name
Revefenacin
Substance Name
Revefenacin
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
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.

Regulatory & Marketing

Labeler Name
Medichem S.a.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
11-18-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53296-0127-0 identifies a specific commercial package of 75 kg in 1 drum of Revefenacin (UNFINISHED drug), a bulk ingredient labeled by Medichem S.a.. This powder is formulated for use and contains revefenacin 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 Medichem S.a. on November 18, 2020. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Medichem S.a. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53296012700. 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 (5-4-1)
53296-0127-0
11-Digit CMS (5-4-2)
53296-0127-00

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