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  5. NDC Package Code: 53044-828-01 Baloxavir Marboxil

NDC Package 53044-828-01 Baloxavir Marboxil

Tablet, Coated - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
53044-828-01
Package Description:
100000 TABLET, COATED in 1 DRUM
Product Code:
53044-828
Non-Proprietary Name:
Baloxavir Marboxil
Substance Name:
Baloxavir Marboxil
Usage Information:
Baloxavir marboxil is an antiviral medication used to treat the flu (influenza) if your symptoms started less than 48 hours ago. It helps make the symptoms (such as stuffy nose, cough, sore throat, fever/chills, aches, tiredness) less severe and may shorten the recovery time by 1 to 2 days. Baloxavir marboxil works by stopping the flu virus from growing. It will not treat other kinds of infection besides the flu virus. Baloxavir marboxil is not a substitute for the flu vaccine. (See also Notes section.)
11-Digit NDC Billing Format:
53044082801
Product Type:
Drug For Further Processing
Labeler Name:
Shionogi Pharma Co., Ltd.
Dosage Form:
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Active Ingredient(s):
  • BALOXAVIR MARBOXIL 20 mg/1
    • Sample Package:
    N/A
    Marketing Category:
    DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
    Start Marketing Date:
    10-24-2018
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Unfinished Product:
    Yes
    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.

    Frequently Asked Questions

    What is NDC 53044-828-01?

    The NDC Packaged Code 53044-828-01 is assigned to an UNFINISHED drug package of 100000 tablet, coated in 1 drum of Baloxavir Marboxil, drug for further processing labeled by Shionogi Pharma Co., Ltd.. The product's dosage form is tablet, coated and is administered via form.

    Is NDC 53044-828 included in the NDC Directory?

    Yes, Baloxavir Marboxil is an UNFINISHED PRODUCT with code 53044-828 that is active and included in the NDC Directory. The product was first marketed by Shionogi Pharma Co., Ltd. on October 24, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 53044-828-01?

    The 11-digit format is 53044082801. 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
    5-3-253044-828-015-4-253044-0828-01