Macitentan Tablet, Film Coated
NDC Package 70710-1166-3

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

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 Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-1166 and is authorized under FDA application ANDA211224.

Identification & Billing

NDC Package Code
70710-1166-3
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
70710-1166
11-Digit Billing Format
70710116603
RxNorm Crosswalk
RxCUI: 1442137 - macitentan 10 MG Oral Tablet

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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MACITENTAN 10 mg/1
Pharmacologic Class
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
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA211224
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-05-2025
Listing Expiration
12-31-2027
Exclude Flag
N
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 (70710-1166). Click a package code to view its specific billing and regulatory data.

70710-1166-5
5 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK (70710-1166-4)

* 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 70710-1166-3 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Macitentan, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. This tablet, film coated is formulated for oral 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 Zydus Pharmaceuticals Usa Inc. on November 05, 2025. The current certification is valid through December 31, 2027.

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 Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710116603. 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)
70710-1166-3
11-Digit CMS (5-4-2)
70710-1166-03

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