Zafirlukast Tablet, Film Coated
NDC Package 68084-059-21

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, film coated delivery system. Marketed by American Health Packaging, this product is identified by NDC 68084-059 and is authorized under FDA application ANDA090372.

Identification & Billing

NDC Package Code
68084-059-21
Package Description
30 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-059-11)
Product Code
68084-059
11-Digit Billing Format
68084005921
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
RxCUI: 199655 - zafirlukast 20 MG Oral Tablet

Clinical Specifications

Proprietary Name
Zafirlukast
Non-Proprietary Name
Zafirlukast
Substance Name
Zafirlukast
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ZAFIRLUKAST 20 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
American Health Packaging
Product Type
Human Prescription Drug
FDA Application #
ANDA090372
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-03-2013
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 68084-059-21 identifies a specific commercial package of 30 blister pack in 1 box, unit-dose / 1 tablet, film coated in 1 blister pack (68084-059-11) of Zafirlukast, a human prescription drug labeled by American Health Packaging. This tablet, film 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 American Health Packaging on June 03, 2013. 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 American Health Packaging product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68084005921. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
68084-059-21
11-Digit CMS (5-4-2)
68084-0059-21

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