Accolate
NDC Package 64380-178-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Strides Pharma Science Limited, this product is identified by NDC 64380-178 and is authorized under FDA application NDA020547.

Identification & Billing

NDC Package Code
64380-178-01
Package Description
60 TABLET, FILM COATED in 1 BOTTLE
Product Code
64380-178
11-Digit Billing Format
64380017801
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA

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
Strides Pharma Science Limited
FDA Application #
NDA020547
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-02-2023
End Marketing Date
03-12-2026
Listing Expiration
03-12-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 64380-178-01 identifies a specific commercial package of 60 tablet, film coated in 1 bottle of Accolate, labeled by Strides Pharma Science Limited. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. 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 Strides Pharma Science Limited on January 02, 2023. The current certification is valid through March 12, 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 Strides Pharma Science Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64380017801. 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)
64380-178-01
11-Digit CMS (5-4-2)
64380-0178-01

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