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  5. NDC Package Code: 68382-447-01 Bosentan

NDC Package 68382-447-01 Bosentan

Tablet, 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:
68382-447-01
Package Description:
100 TABLET, COATED in 1 BOTTLE
Product Code:
68382-447
Proprietary Name:
Bosentan
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:
68382044701
NDC to RxNorm Crosswalk:
  • RxCUI: 349253 - bosentan 62.5 MG Oral Tablet
  • RxCUI: 349253 - bosentan (as bosentan hydrochloride) 62.5 MG Oral Tablet
  • RxCUI: 656659 - bosentan 125 MG Oral Tablet
  • RxCUI: 656659 - bosentan (as bosentan hydrochloride) 125 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Pharmaceuticals Usa Inc.
    Dosage Form:
    Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • BOSENTAN 125 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:
    ANDA207760
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-01-2019
    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
    68382-447-05500 TABLET, COATED in 1 BOTTLE
    68382-447-1460 TABLET, COATED in 1 BOTTLE
    68382-447-28180 TABLET, COATED in 1 BOTTLE
    68382-447-7710 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK (68382-447-30)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 68382-447-01?

    The NDC Packaged Code 68382-447-01 is assigned to a package of 100 tablet, coated in 1 bottle of Bosentan, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is tablet, coated and is administered via oral form.

    Is NDC 68382-447 included in the NDC Directory?

    Yes, Bosentan with product code 68382-447 is active and included in the NDC Directory. The product was first marketed by Zydus Pharmaceuticals Usa Inc. on May 01, 2019 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 68382-447-01?

    The 11-digit format is 68382044701. 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
    5-3-268382-447-015-4-268382-0447-01