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  5. NDC Package Code: 66215-501-30 Opsumit

NDC Package 66215-501-30 Opsumit

Macitentan 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:
66215-501-30
Package Description:
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
66215-501
Proprietary Name:
Opsumit
Non-Proprietary Name:
Macitentan
Substance Name:
Macitentan
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.
11-Digit NDC Billing Format:
66215050130
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1442137 - macitentan 10 MG Oral Tablet
  • RxCUI: 1442143 - Opsumit 10 MG Oral Tablet
  • RxCUI: 1442143 - macitentan 10 MG Oral Tablet [Opsumit]
    • 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
    • Pharmacologic Class(es):
  • Endothelin Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Endothelin Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA204410
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-04-2013
    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
    66215-501-151 BLISTER PACK in 1 CARTON / 15 TABLET, FILM COATED in 1 BLISTER PACK

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 66215-501-30?

    The NDC Packaged Code 66215-501-30 is assigned to a package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Opsumit, 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.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 66215-501 included in the NDC Directory?

    Yes, Opsumit with product code 66215-501 is active and included in the NDC Directory. The product was first marketed by Actelion Pharmaceuticals Us, Inc. on November 04, 2013 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 NDC billing unit for package 66215-501-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 66215-501-30?

    The 11-digit format is 66215050130. 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
    5-3-266215-501-305-4-266215-0501-30