Zafirlukast Tablet, Coated
NDC Package 42291-970-60

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Zafirlukast tablets is zafirlukast is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. This formulation utilizes a tablet, coated delivery system. Marketed by Avkare, this product is identified by NDC 42291-970 and is authorized under FDA application NDA020547.

Identification & Billing

NDC Package Code
42291-970-60
Package Description
60 TABLET, COATED in 1 BOTTLE
Product Code
42291-970
11-Digit Billing Format
42291097060
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zafirlukast
Non-Proprietary Name
Zafirlukast
Substance Name
Zafirlukast
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZAFIRLUKAST 10 mg/1
Pharmacologic Class
Usage Information
Zafirlukast 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.

Regulatory & Marketing

Labeler Name
Avkare
Product Type
Human Prescription Drug
FDA Application #
NDA020547
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-05-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

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 42291-970-60 identifies a specific commercial package of 60 tablet, coated in 1 bottle of Zafirlukast, a human prescription drug labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This tablet, coated is formulated for oral use and contains zafirlukast 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 Avkare on April 05, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Zafirlukast 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.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291097060. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 total billable units per package. 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)
42291-970-60
11-Digit CMS (5-4-2)
42291-0970-60

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