Zafirlukast Tablet, Film Coated
NDC Package 55111-626-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Dr. Reddys Laboratories Limited, this product is identified by NDC 55111-626 and is authorized under FDA application ANDA090372.

Identification & Billing

NDC Package Code
55111-626-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
55111-626
11-Digit Billing Format
55111062601
RxNorm Crosswalk

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
Dr. Reddys Laboratories Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA090372
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-18-2010
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55111-626). Click a package code to view its specific billing and regulatory data.

55111-626-05
500 TABLET, FILM COATED in 1 BOTTLE
55111-626-30
30 TABLET, FILM COATED in 1 BOTTLE
55111-626-60
60 TABLET, FILM COATED in 1 BOTTLE
55111-626-78
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-626-79)

* 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 55111-626-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Zafirlukast, a human prescription drug labeled by Dr. Reddys Laboratories Limited. 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 Dr. Reddys Laboratories Limited on November 18, 2010. 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 Dr. Reddys Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111062601. 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)
55111-626-01
11-Digit CMS (5-4-2)
55111-0626-01

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