Zileuton Tablet, Multilayer, Extended Release
NDC Package 51407-741-12

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, multilayer, extended release delivery system. Marketed by Golden State Medical Supply, Inc., this product is identified by NDC 51407-741 and is authorized under FDA application ANDA212670.

Identification & Billing

NDC Package Code
51407-741-12
Package Description
120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
Product Code
51407-741
11-Digit Billing Format
51407074112
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, Multilayer, Extended Release - A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form.
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
Golden State Medical Supply, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212670
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-16-2019
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 51407-741-12 identifies a specific commercial package of 120 tablet, multilayer, extended release in 1 bottle of Zileuton, a human prescription drug labeled by Golden State Medical Supply, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package. This tablet, multilayer, 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 Golden State Medical Supply, Inc. on December 16, 2019. 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 Golden State Medical Supply, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51407074112. 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)
51407-741-12
11-Digit CMS (5-4-2)
51407-0741-12

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