Bosentan
NDC Package 49884-059-02

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.

Bosentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). Marketed by Par Pharmaceutical, Inc., this product is identified by NDC 49884-059 and is authorized under FDA application ANDA205699.

Identification & Billing

NDC Package Code
49884-059-02
Package Description
60 TABLET, FILM COATED in 1 CONTAINER
Product Code
49884-059
11-Digit Billing Format
49884005902
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
Bosentan
Dosage Form
-
Usage Information
Bosentan 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 from the disease, and improve your ability to exercise.

Regulatory & Marketing

Labeler Name
Par Pharmaceutical, Inc.
FDA Application #
ANDA205699
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-29-2019
End Marketing Date
11-30-2023
Listing Expiration
11-30-2023
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 49884-059-02 identifies a specific commercial package of 60 tablet, film coated in 1 container of Bosentan, labeled by Par Pharmaceutical, Inc.. 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 Par Pharmaceutical, Inc. on April 29, 2019. The current certification is valid through November 30, 2023.

What are the primary indications for this medication?

Bosentan 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 from the disease, and improve your ability to exercise.

How is this Par Pharmaceutical, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49884005902. 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)
49884-059-02
11-Digit CMS (5-4-2)
49884-0059-02

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