Fexinidazole Tablet
NDC Package 0024-4512-24

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Fexinidazole tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. This formulation utilizes a tablet delivery system. Marketed by Sanofi-aventis U.s. Llc, this product is identified by NDC 0024-4512 and is authorized under FDA application NDA214429.

Identification & Billing

NDC Package Code
0024-4512-24
Package Description
24 TABLET in 1 DOSE PACK
Product Code
0024-4512
11-Digit Billing Format
00024451224
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
24 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fexinidazole
Non-Proprietary Name
Fexinidazole
Substance Name
Fexinidazole
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FEXINIDAZOLE 600 mg/1
Pharmacologic Class
Usage Information
Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg.

Regulatory & Marketing

Labeler Name
Sanofi-aventis U.s. Llc
Product Type
Human Prescription Drug
FDA Application #
NDA214429
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-16-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0024-4512). Click a package code to view its specific billing and regulatory data.

0024-4512-14
14 TABLET in 1 DOSE PACK

* 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 0024-4512-24 identifies a specific commercial package of 24 tablet in 1 dose pack of Fexinidazole, a human prescription drug labeled by Sanofi-aventis U.s. Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 24 billable units per package. This tablet is formulated for oral use and contains fexinidazole 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 Sanofi-aventis U.s. Llc on July 16, 2021. The current certification is valid through December 31, 2026.

How is this Sanofi-aventis U.s. Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00024451224. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 24 total billable units per package. 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 (4-4-2)
0024-4512-24
11-Digit CMS (5-4-2)
00024-4512-24

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