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  5. NDC Package Code: 53044-002-01 Naldemedine Tosylate

NDC Package 53044-002-01 Naldemedine Tosylate

Powder - 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:
53044-002-01
Package Description:
.3 kg in 1 DRUM
Product Code:
53044-002
Non-Proprietary Name:
Naldemedine Tosylate
Substance Name:
Naldemedine Tosylate
Usage Information:
This medication is used to treat constipation caused by opioid medication. It blocks the effect of opioids on the gut without blocking the effect on pain. Naldemedine belongs to a class of medications known as opioid antagonists.
11-Digit NDC Billing Format:
53044000201
Product Type:
Bulk Ingredient
Labeler Name:
Shionogi Pharma Co., Ltd.
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s):
  • NALDEMEDINE TOSYLATE 1 kg/kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    03-23-2017
    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 53044-002-01?

    The NDC Packaged Code 53044-002-01 is assigned to an UNFINISHED drug package of .3 kg in 1 drum of Naldemedine Tosylate, a bulk ingredient labeled by Shionogi Pharma Co., Ltd.. The product's dosage form is powder and is administered via form.

    Is NDC 53044-002 included in the NDC Directory?

    Yes, Naldemedine Tosylate is an UNFINISHED PRODUCT with code 53044-002 that is active and included in the NDC Directory. The product was first marketed by Shionogi Pharma Co., Ltd. on March 23, 2017 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 53044-002-01?

    The 11-digit format is 53044000201. 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
    5-3-253044-002-015-4-253044-0002-01