Macitentan Tablet, Film Coated
NDC Package 46014-5010-1

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 tablets is macitentan is used to treat high blood pressure in the lungs (pulmonary arterial hypertension). This formulation utilizes a tablet, film coated delivery system. Marketed by Excella Gmbh & Co. Kg, this product is identified by NDC 46014-5010.

Identification & Billing

NDC Package Code
46014-5010-1
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
46014-5010
11-Digit Billing Format
46014501001

Clinical Specifications

Proprietary Name
Macitentan
Non-Proprietary Name
Macitentan
Substance Name
Macitentan
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Active Ingredient(s)
MACITENTAN 10 mg/1
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
Excella Gmbh & Co. Kg
Product Type
Human Prescription Drug
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
11-04-2013
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 46014-5010-1 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Macitentan (UNFINISHED drug), a human prescription drug labeled by Excella Gmbh & Co. Kg. This tablet, film coated 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 Excella Gmbh & Co. Kg on November 04, 2013. 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 Excella Gmbh & Co. Kg product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46014501001. 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 (5-4-1)
46014-5010-1
11-Digit CMS (5-4-2)
46014-5010-01

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