Elexacaftor Powder
NDC Package 24538-445-01

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.

Elexacaftor powders is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a powder delivery system. Marketed by Shanghai Syntheall Pharmaceutical Co., Ltd., this product is identified by NDC 24538-445.

Identification & Billing

NDC Package Code
24538-445-01
Package Description
20 kg in 1 DRUM
Product Code
24538-445
11-Digit Billing Format
24538044501

Clinical Specifications

Proprietary Name
Elexacaftor
Non-Proprietary Name
Elexacaftor
Substance Name
Elexacaftor
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)
ELEXACAFTOR 1 kg/kg

Regulatory & Marketing

Labeler Name
Shanghai Syntheall Pharmaceutical Co., Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-21-2019
Listing Expiration
12-31-2027
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 24538-445-01 identifies a specific commercial package of 20 kg in 1 drum of Elexacaftor (UNFINISHED drug), a bulk ingredient labeled by Shanghai Syntheall Pharmaceutical Co., Ltd.. This powder is formulated for use and contains elexacaftor 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 Shanghai Syntheall Pharmaceutical Co., Ltd. on October 21, 2019. The current certification is valid through December 31, 2027.

How is this Shanghai Syntheall Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 24538044501. 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 (5-3-2)
24538-445-01
11-Digit CMS (5-4-2)
24538-0445-01

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