Ambrisentan
NDC Package 42291-019-30

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.

Ambrisentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). Marketed by Avkare, this product is identified by NDC 42291-019 and is authorized under FDA application ANDA208354.

Identification & Billing

NDC Package Code
42291-019-30
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
42291-019
11-Digit Billing Format
42291001930

Clinical Specifications

Proprietary Name
Ambrisentan
Dosage Form
-
Usage Information
Ambrisentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelin-1). This medication blocks the effects of endothelin-1, thereby helping to decrease the blood pressure in the lungs, slow the worsening of symptoms, and improve your ability to exercise.

Regulatory & Marketing

Labeler Name
Avkare
FDA Application #
ANDA208354
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-18-2020
End Marketing Date
03-08-2021
Listing Expiration
03-08-2021
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 42291-019-30 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Ambrisentan, labeled by Avkare. 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 Avkare on December 18, 2020. The current certification is valid through March 08, 2021.

What are the primary indications for this medication?

Ambrisentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This condition is thought to be caused by increased levels of a certain natural substance (endothelin-1). This medication blocks the effects of endothelin-1, thereby helping to decrease the blood pressure in the lungs, slow the worsening of symptoms, and improve your ability to exercise.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291001930. 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)
42291-019-30
11-Digit CMS (5-4-2)
42291-0019-30

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