Zileuton Tablet, Multilayer, Extended Release
NDC 64380-189

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 64380-189?
  5. Zileuton Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Zileuton is a ANDA-approved product labeled by Strides Pharma Science Limited. Zileuton is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. It is supplied as a white tablet, multilayer, extended release for oral administration. This product entry covers the primary NDC 64380-189 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
64380-189
Proprietary Name:
Zileuton
Non-Proprietary Name: [1]
Zileuton
Substance Name: [2]
Zileuton
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Strides Pharma Science Limited
Labeler Code:
64380
Product Label ID:
a826d16f-df07-447b-b050-b9a02ea1f89e
FDA Application Number: [6]
ANDA212670
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
10-15-2022
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - ONE RED LAYER BETWEEN TWO WHITE LAYERS)
Shape:
OVAL (C48345)
Size(s):
19 MM
Imprint(s):
P723
Score:
1

Code Structure Chart

Product Details

What is NDC 64380-189?

The NDC code 64380-189 is assigned by the FDA to the product Zileuton. This pharmaceutical product is labeled by Strides Pharma Science Limited and is currently categorized as listed product. The medication is a tablet, multilayer, extended release administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 64380-189-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

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 full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".