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  5. NDC Package Code: 63204-1501-0 Carbamide Peroxide

NDC Package 63204-1501-0 Carbamide Peroxide

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:
63204-1501-0
Package Description:
25 kg in 1 BAG
Product Code:
63204-1501
Non-Proprietary Name:
Carbamide Peroxide
Substance Name:
Carbamide Peroxide
Usage Information:
This medication is used to treat earwax buildup. It helps to soften, loosen, and remove the earwax. Too much earwax can block the ear canal and reduce hearing. This medication releases oxygen and starts to foam when it comes in contact with the skin. The foaming helps break up and remove the earwax. Consult your doctor before using this product in children younger than 12 years.
11-Digit NDC Billing Format:
63204150100
Product Type:
Bulk Ingredient
Labeler Name:
United Initiators Gmbh
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):
  • CARBAMIDE PEROXIDE 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:
    01-10-2024
    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
    63204-1501-15 kg in 1 BAG

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 63204-1501-0?

    The NDC Packaged Code 63204-1501-0 is assigned to an UNFINISHED drug package of 25 kg in 1 bag of Carbamide Peroxide, a bulk ingredient labeled by United Initiators Gmbh. The product's dosage form is powder and is administered via form.

    Is NDC 63204-1501 included in the NDC Directory?

    Yes, Carbamide Peroxide is an UNFINISHED PRODUCT with code 63204-1501 that is active and included in the NDC Directory. The product was first marketed by United Initiators Gmbh on January 10, 2024 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 63204-1501-0?

    The 11-digit format is 63204150100. 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 5-4-1 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
    5-4-163204-1501-05-4-263204-1501-00