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  5. NDC Package Code: 0024-4512-14 Fexinidazole

NDC Package 0024-4512-14 Fexinidazole

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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:
0024-4512-14
Package Description:
14 TABLET in 1 DOSE PACK
Product Code:
0024-4512
Proprietary Name:
Fexinidazole
Non-Proprietary Name:
Fexinidazole
Substance Name:
Fexinidazole
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.
11-Digit NDC Billing Format:
00024451214
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
14 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2564151 - fexinidazole 600 MG Oral Tablet
  • RxCUI: 2564152 - {24 (fexinidazole 600 MG Oral Tablet) } Pack
  • RxCUI: 2564152 - fexinidazole 600 MG Tablet 10-Day Dose Pack (35 KG+)
  • RxCUI: 2564153 - {14 (fexinidazole 600 MG Oral Tablet) } Pack
  • RxCUI: 2564153 - fexinidazole 600 MG Tablet 10-Day Dose Pack (20 KG - < 35 KG)
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sanofi-aventis U.s. Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FEXINIDAZOLE 600 mg/1
    • Pharmacologic Class(es):
  • Cytochrome P450 1A2 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 1A2 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2B6 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 2B6 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 2D6 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A5 Inhibitors - [MoA] (Mechanism of Action)
  • Multidrug and Toxin Extrusion Transporter 1 Inhibitors - [MoA] (Mechanism of Action)
  • Multidrug and Toxin Extrusion Transporter 2 K Inhibitors - [MoA] (Mechanism of Action)
  • Nitroimidazole Antimicrobial - [EPC] (Established Pharmacologic Class)
  • Nitroimidazoles - [CS]
  • Organic Anion Transporter 1 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Anion Transporter 3 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Anion Transporting Polypeptide 1B1 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Anion Transporting Polypeptide 1B3 Inhibitors - [MoA] (Mechanism of Action)
  • Organic Cation Transporter 2 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA214429
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    07-16-2021
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0024-4512-2424 TABLET in 1 DOSE PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0024-4512-14?

    The NDC Packaged Code 0024-4512-14 is assigned to a package of 14 tablet in 1 dose pack of Fexinidazole, a human prescription drug labeled by Sanofi-aventis U.s. Llc. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 14 billable units per package.

    Is NDC 0024-4512 included in the NDC Directory?

    Yes, Fexinidazole with product code 0024-4512 is active and included in the NDC Directory. The product was first marketed by Sanofi-aventis U.s. Llc on July 16, 2021 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 NDC billing unit for package 0024-4512-14?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 14.

    What is the 11-digit format for NDC 0024-4512-14?

    The 11-digit format is 00024451214. 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 4-4-2 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
    4-4-20024-4512-145-4-200024-4512-14