Accolate
NDC Package 54868-4172-2

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Accolate is zafirlukast is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4172 and is authorized under FDA application NDA020547.

Identification & Billing

NDC Package Code
54868-4172-2
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
54868-4172
11-Digit Billing Format
54868417202

Clinical Specifications

Proprietary Name
Accolate
Dosage Form
-
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
Physicians Total Care, Inc.
FDA Application #
NDA020547
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-26-1996
End Marketing Date
09-30-2011
Listing Expiration
09-30-2011
Exclude Flag
D
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 (54868-4172). Click a package code to view its specific billing and regulatory data.

54868-4172-0
6 TABLET, FILM COATED in 1 BOTTLE
54868-4172-1
30 TABLET, FILM COATED in 1 BOTTLE

* 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 54868-4172-2 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Accolate, labeled by Physicians Total Care, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on September 26, 1996. The current certification is valid through September 30, 2011.

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 Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868417202. 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 (5-4-1)
54868-4172-2
11-Digit CMS (5-4-2)
54868-4172-02

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