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  5. NDC Package Code: 66215-101-03 Tracleer

NDC Package 66215-101-03 Tracleer

Bosentan 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:
66215-101-03
Package Description:
10 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
66215-101
Proprietary Name:
Tracleer
Non-Proprietary Name:
Bosentan
Substance Name:
Bosentan
Usage Information:
Bosentan 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, thereby helping to decrease the blood pressure in the lungs, slow the worsening of symptoms from the disease, and improve your ability to exercise.
11-Digit NDC Billing Format:
66215010103
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
10 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1989081 - bosentan 32 MG Tablet for Oral Suspension
  • RxCUI: 1989085 - Tracleer 32 MG Tablet for Oral Suspension
  • RxCUI: 1989085 - bosentan 32 MG Tablet for Oral Suspension [Tracleer]
  • RxCUI: 349253 - bosentan 62.5 MG Oral Tablet
  • RxCUI: 349253 - bosentan (as bosentan hydrochloride) 62.5 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):
  • BOSENTAN 62.5 mg/1
    • Pharmacologic Class(es):
  • Cytochrome P450 2C9 Inducers - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A Inducers - [MoA] (Mechanism of Action)
  • Endothelin Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Endothelin Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA021290
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-20-2001
    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
    66215-101-061 BOTTLE, PLASTIC in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 66215-101-03?

    The NDC Packaged Code 66215-101-03 is assigned to a package of 10 blister pack in 1 carton / 3 tablet, film coated in 1 blister pack of Tracleer, 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 10 billable units per package.

    Is NDC 66215-101 included in the NDC Directory?

    Yes, Tracleer with product code 66215-101 is active and included in the NDC Directory. The product was first marketed by Actelion Pharmaceuticals Us, Inc. on November 20, 2001 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 66215-101-03?

    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 10.

    What is the 11-digit format for NDC 66215-101-03?

    The 11-digit format is 66215010103. 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
    5-3-266215-101-035-4-266215-0101-03