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  5. NDC Package Code: 10122-901-12 Zyflo

NDC Package 10122-901-12 Zyflo

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

Table of Contents

    1. Package Information
    2. 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:
10122-901-12
Package Description:
120 TABLET in 1 BOTTLE
Product Code:
10122-901
Proprietary Name:
Zyflo
Non-Proprietary Name:
Zileuton
Substance Name:
Zileuton
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.
11-Digit NDC Billing Format:
10122090112
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
120 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 199904 - zileuton 600 MG Oral Tablet
  • RxCUI: 211777 - Zyflo 600 MG Oral Tablet
  • RxCUI: 211777 - zileuton 600 MG Oral Tablet [Zyflo]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Chiesi Usa, Inc.
    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):
  • ZILEUTON 600 mg/1
    • Pharmacologic Class(es):
  • 5-Lipoxygenase Inhibitor - [EPC] (Established Pharmacologic Class)
  • 5-Lipoxygenase Inhibitors - [MoA] (Mechanism of Action)
  • Decreased Leukotriene Production - [PE] (Physiologic Effect)
    • Sample Package:
    No
    FDA Application Number:
    NDA020471
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    12-06-1996
    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.

    Frequently Asked Questions

    What is NDC 10122-901-12?

    The NDC Packaged Code 10122-901-12 is assigned to a package of 120 tablet in 1 bottle of Zyflo, a human prescription drug labeled by Chiesi Usa, Inc.. 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 120 billable units per package.

    Is NDC 10122-901 included in the NDC Directory?

    Yes, Zyflo with product code 10122-901 is active and included in the NDC Directory. The product was first marketed by Chiesi Usa, Inc. on December 06, 1996 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 10122-901-12?

    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 120.

    What is the 11-digit format for NDC 10122-901-12?

    The 11-digit format is 10122090112. 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
    5-3-210122-901-125-4-210122-0901-12