Zileuton Powder
NDC Package 59285-035-01

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.

Zileuton powders is zileuton is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. This formulation utilizes a powder delivery system. Marketed by Optimus Drugs Private Limited, this product is identified by NDC 59285-035.

Identification & Billing

NDC Package Code
59285-035-01
Package Description
50 kg in 1 DRUM
Product Code
59285-035
11-Digit Billing Format
59285003501

Clinical Specifications

Proprietary Name
Zileuton
Non-Proprietary Name
Zileuton
Substance Name
Zileuton
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)
ZILEUTON 1 kg/kg
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
Optimus Drugs Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
12-29-2020
Listing Expiration
12-31-2026
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 59285-035-01 identifies a specific commercial package of 50 kg in 1 drum of Zileuton (UNFINISHED drug), a bulk ingredient labeled by Optimus Drugs Private Limited. This powder is formulated for 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 Optimus Drugs Private Limited on December 29, 2020. 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 Optimus Drugs Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59285003501. 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)
59285-035-01
11-Digit CMS (5-4-2)
59285-0035-01

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