NDC Package 68180-169-26 Zileuton

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
68180-169-26
Package Description:
180 TABLET, EXTENDED RELEASE in 1 BOTTLE
Product Code:
Proprietary Name:
Zileuton
Usage Information:
Zileuton extended-release tabletis indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton extended-release tabletis not indicated for use in the reversal of bronchospasm in acute asthma attacks.  Therapy with zileuton extended-release tablet can be continued during acute exacerbations of asthma. 
11-Digit NDC Billing Format:
68180016926
NDC to 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
  • Labeler Name:
    Lupin Pharmaceuticals, Inc.
    Sample Package:
    No
    Start Marketing Date:
    08-10-2020
    Listing Expiration Date:
    12-31-2022
    Exclude Flag:
    I
    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
    68180-169-0760 TABLET, EXTENDED RELEASE in 1 BOTTLE
    68180-169-16120 TABLET, EXTENDED RELEASE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68180-169-26?

    The NDC Packaged Code 68180-169-26 is assigned to a package of 180 tablet, extended release in 1 bottle of Zileuton, labeled by Lupin Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

    Is NDC 68180-169 included in the NDC Directory?

    No, Zileuton with product code 68180-169 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Lupin Pharmaceuticals, Inc. on August 10, 2020 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 68180-169-26?

    The 11-digit format is 68180016926. 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 5-3-2 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
    5-3-268180-169-265-4-268180-0169-26