Opsynvi Tablet, Film Coated
NDC Package 66215-812-07

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

Opsynvi (macitentan and tadalafil) tablets is oPSYNVI is the combination of macitentan and tadalafil indicated for the chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO Functional Class (FC) II–III).Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability [see Clinical Studies (14.1)]. This formulation utilizes a tablet, film coated delivery system. Marketed by Actelion Pharmaceuticals Us, Inc., this product is identified by NDC 66215-812 and is authorized under FDA application NDA218490.

Identification & Billing

NDC Package Code
66215-812-07
Package Description
1 BOTTLE in 1 CARTON / 7 TABLET, FILM COATED in 1 BOTTLE
Product Code
66215-812
11-Digit Billing Format
66215081207
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Opsynvi
Non-Proprietary Name
Macitentan And Tadalafil
Substance Name
Macitentan; Tadalafil
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)
Pharmacologic Class
Usage Information
OPSYNVI is the combination of macitentan and tadalafil indicated for the chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO Group I and WHO Functional Class (FC) II–III).Individually, macitentan reduces the risk of clinical worsening events and hospitalization, and tadalafil improves exercise ability [see Clinical Studies (14.1)] .

Regulatory & Marketing

Labeler Name
Actelion Pharmaceuticals Us, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA218490
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-22-2024
Listing Expiration
12-31-2026
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 (66215-812). Click a package code to view its specific billing and regulatory data.

66215-812-08
1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK (66215-812-01)
66215-812-30
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE

* 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 66215-812-07 identifies a specific commercial package of 1 bottle in 1 carton / 7 tablet, film coated in 1 bottle of Opsynvi, a human prescription drug labeled by Actelion Pharmaceuticals Us, Inc.. This tablet, film coated is formulated for oral use and contains macitentan; tadalafil 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 Actelion Pharmaceuticals Us, Inc. on March 22, 2024. The current certification is valid through December 31, 2026.

How is this Actelion Pharmaceuticals Us, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66215081207. 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)
66215-812-07
11-Digit CMS (5-4-2)
66215-0812-07

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