Montelukast
NDC Package 70357-003-30

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.

Montelukast is a . Marketed by Ase Direct, Inc., this product is identified by NDC 70357-003 and is authorized under FDA application ANDA203037.

Identification & Billing

NDC Package Code
70357-003-30
Package Description
30 TABLET, CHEWABLE in 1 BOTTLE
Product Code
70357-003
11-Digit Billing Format
70357000330

Clinical Specifications

Proprietary Name
Montelukast
Dosage Form
-

Regulatory & Marketing

Labeler Name
Ase Direct, Inc.
FDA Application #
ANDA203037
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2014
End Marketing Date
12-31-2016
Listing Expiration
12-31-2016
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 (70357-003). Click a package code to view its specific billing and regulatory data.

70357-003-05
500 TABLET, CHEWABLE in 1 BOTTLE
70357-003-90
90 TABLET, CHEWABLE 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 70357-003-30 identifies a specific commercial package of 30 tablet, chewable in 1 bottle of Montelukast, labeled by Ase Direct, 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 Ase Direct, Inc. on December 01, 2014. The current certification is valid through December 31, 2016.

How is this Ase Direct, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70357000330. 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)
70357-003-30
11-Digit CMS (5-4-2)
70357-0003-30

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