Macitentan Powder
NDC Package 11722-058-00

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Macitentan powders is macitentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This formulation utilizes a powder delivery system. Marketed by Tapi Croatia Industries Ltd., this product is identified by NDC 11722-058.

Identification & Billing

NDC Package Code
11722-058-00
Package Description
1 kg in 1 CARTON
Product Code
11722-058
11-Digit Billing Format
11722005800

Clinical Specifications

Proprietary Name
Macitentan
Non-Proprietary Name
Macitentan
Substance Name
Macitentan
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
MACITENTAN 100 kg/100kg
Usage Information
Macitentan 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, which helps decrease the blood pressure in the lungs, and reduces the risk of worsening of symptoms and hospital stays due to the disease.

Regulatory & Marketing

Labeler Name
Tapi Croatia Industries Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-14-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 11722-058-00 identifies a specific commercial package of 1 kg in 1 carton of Macitentan (UNFINISHED drug), a bulk ingredient labeled by Tapi Croatia Industries Ltd.. This powder is formulated for use and contains macitentan as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Tapi Croatia Industries Ltd. on July 14, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Macitentan 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, which helps decrease the blood pressure in the lungs, and reduces the risk of worsening of symptoms and hospital stays due to the disease.

How is this Tapi Croatia Industries Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11722005800. 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)
11722-058-00
11-Digit CMS (5-4-2)
11722-0058-00

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