Zileuton Tablet, Film Coated, Extended Release
NDC Package 31722-044-12

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

Package Information

Zileuton tablets is zileuton is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. This formulation utilizes a tablet, film coated, extended release delivery system. Marketed by Camber Pharmaceuticals, Inc., this product is identified by NDC 31722-044 and is authorized under FDA application ANDA215742.

Identification & Billing

NDC Package Code
31722-044-12
Package Description
120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
31722-044
11-Digit Billing Format
31722004412
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
120 EA
RxNorm Crosswalk
  • RxCUI: 730834 - zileuton 600 MG 12HR Extended Release Oral Tablet
  • RxCUI: 730834 - 12 HR zileuton 600 MG Extended Release Oral Tablet
  • RxCUI: 730834 - zileuton 600 MG 12 HR Extended Release Oral Tablet

Clinical Specifications

Proprietary Name
Zileuton
Non-Proprietary Name
Zileuton
Substance Name
Zileuton
Dosage Form
Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZILEUTON 600 mg/1
Pharmacologic Class
Usage Information
Zileuton is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you maintain your normal activities and cuts down on time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, salbutamol) as prescribed. This drug is not recommended for use in children younger than 12 years due to possible risk of liver problems.

Regulatory & Marketing

Labeler Name
Camber Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA215742
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-11-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 31722-044-12 identifies a specific commercial package of 120 tablet, film coated, extended release in 1 bottle of Zileuton, a human prescription drug labeled by Camber Pharmaceuticals, Inc.. This tablet, film coated, extended release is formulated for oral use and contains zileuton 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 Camber Pharmaceuticals, Inc. on October 11, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Zileuton is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Controlling symptoms of asthma helps you maintain your normal activities and cuts down on time lost from work or school. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, salbutamol) as prescribed. This drug is not recommended for use in children younger than 12 years due to possible risk of liver problems.

How is this Camber Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 31722004412. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 120 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 (5-3-2)
31722-044-12
11-Digit CMS (5-4-2)
31722-0044-12

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