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  4. NDC Product Code: 68180-169 Zileuton

NDC 68180-169 Zileuton

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68180-169?
  5. Zileuton Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
68180-169
Proprietary Name:
Zileuton
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Lupin Pharmaceuticals, Inc.
Labeler Code:
68180
Product Label ID:
cf392f79-2276-4fe1-8fa8-74afd5150f73
Start Marketing Date: [9]
08-10-2020
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
19 MM
Imprint(s):
LU;R21
Score:
1

Product Packages

NDC Code 68180-169-07

Package Description: 60 TABLET, EXTENDED RELEASE in 1 BOTTLE

NDC Code 68180-169-16

Package Description: 120 TABLET, EXTENDED RELEASE in 1 BOTTLE

Price per Unit: $10.01661 per EA

NDC Code 68180-169-26

Package Description: 180 TABLET, EXTENDED RELEASE in 1 BOTTLE

Product Details

What is NDC 68180-169?

The NDC code 68180-169 is assigned by the FDA to the product Zileuton which is product labeled by Lupin Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 68180-169-07 60 tablet, extended release in 1 bottle , 68180-169-16 120 tablet, extended release in 1 bottle , 68180-169-26 180 tablet, extended release in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Zileuton?

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. 

Which are Zileuton UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Zileuton Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Zileuton?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Patient Education

Zileuton


Zileuton is used to prevent wheezing, shortness of breath, coughing, and chest tightness due to asthma. Zileuton is not used to treat an asthma attack (sudden episode of shortness of breath, wheezing, and coughing) that has already started. Zileuton belongs to a class of medications called leukotriene synthesis inhibitors. It works by stopping the formation of certain natural substances that cause swelling, tightening, and mucus production in the airways.
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* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".