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  5. NDC Package Code: 66215-814-10 Opsynvi

NDC Package 66215-814-10 Opsynvi

Macitentan And Tadalafil Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
66215-814-10
Package Description:
1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (66215-814-01)
Product Code:
66215-814
Proprietary Name:
Opsynvi
Non-Proprietary Name:
Macitentan And Tadalafil
Substance Name:
Macitentan; Tadalafil
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)] .
11-Digit NDC Billing Format:
66215081410
NDC to RxNorm Crosswalk:
  • RxCUI: 2677765 - macitentan 10 MG / tadalafil 20 MG Oral Tablet
  • RxCUI: 2677771 - Opsynvi 10 MG / 20 MG Oral Tablet
  • RxCUI: 2677771 - macitentan 10 MG / tadalafil 20 MG Oral Tablet [Opsynvi]
  • RxCUI: 2677771 - Opsynvi (macitentan 10 MG / tadalafil 20 MG) Oral Tablet
  • RxCUI: 2677773 - macitentan 10 MG / tadalafil 40 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Actelion Pharmaceuticals Us, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • MACITENTAN 10 mg/1
  • TADALAFIL 40 mg/1
    • Pharmacologic Class(es):
  • Endothelin Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Endothelin Receptor Antagonists - [MoA] (Mechanism of Action)
  • Phosphodiesterase 5 Inhibitor - [EPC] (Established Pharmacologic Class)
  • Phosphodiesterase 5 Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA218490
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-22-2024
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    66215-814-301 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 66215-814-10?

    The NDC Packaged Code 66215-814-10 is assigned to a package of 1 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack (66215-814-01) of Opsynvi, a human prescription drug labeled by Actelion Pharmaceuticals Us, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 66215-814 included in the NDC Directory?

    Yes, Opsynvi with product code 66215-814 is active and included in the NDC Directory. The product was first marketed by Actelion Pharmaceuticals Us, Inc. on March 22, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 66215-814-10?

    The 11-digit format is 66215081410. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-266215-814-105-4-266215-0814-10