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  5. NDC Package Code: 82758-505-05 Nintedanib Esylate

NDC Package 82758-505-05 Nintedanib Esylate

Powder - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
82758-505-05
Package Description:
5 kg in 1 DRUM
Product Code:
82758-505
Non-Proprietary Name:
Nintedanib Esylate
Substance Name:
Nintedanib Esylate
Usage Information:
This medication is used to treat certain types of lung disease (idiopathic pulmonary fibrosis- IPF, interstitial lung disease). Both types of lung disease scar and stiffen your lungs, making it hard to breathe. Nintedanib may help slow down the worsening of your lung disease.
11-Digit NDC Billing Format:
82758050505
Product Type:
Bulk Ingredient
Labeler Name:
Hubei Humanwell Chengtian Pharmaceutical 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):
  • NINTEDANIB ESYLATE 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:
    05-30-2022
    Listing Expiration Date:
    12-31-2025
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    82758-505-011 kg in 1 DRUM
    82758-505-1010 kg in 1 DRUM
    82758-505-2020 kg in 1 DRUM

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 82758-505-05?

    The NDC Packaged Code 82758-505-05 is assigned to an UNFINISHED drug package of 5 kg in 1 drum of Nintedanib Esylate, a bulk ingredient labeled by Hubei Humanwell Chengtian Pharmaceutical Co., Ltd.. The product's dosage form is powder and is administered via form.

    Is NDC 82758-505 included in the NDC Directory?

    Yes, Nintedanib Esylate is an UNFINISHED PRODUCT with code 82758-505 that is active and included in the NDC Directory. The product was first marketed by Hubei Humanwell Chengtian Pharmaceutical Co., Ltd. on May 30, 2022 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 82758-505-05?

    The 11-digit format is 82758050505. 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
    5-3-282758-505-055-4-282758-0505-05