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  5. NDC Package Code: 22365-012-12 Ursodiol

NDC Package 22365-012-12 Ursodiol

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:
22365-012-12
Package Description:
25 kg in 1 DRUM
Product Code:
22365-012
Non-Proprietary Name:
Ursodiol
Substance Name:
Ursodiol
Usage Information:
Ursodiol is used to dissolve certain types of gallstones, to prevent gallstones from forming in obese patients who are losing weight rapidly, and to treat a certain type of liver disease (primary biliary cholangitis). Ursodiol is a bile acid.
11-Digit NDC Billing Format:
22365001212
Product Type:
Bulk Ingredient
Labeler Name:
Arch Pharmalabs Limited
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):
  • URSODIOL 25 kg/25kg
    • Sample Package:
    N/A
    Marketing Category:
    BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
    Start Marketing Date:
    12-17-2018
    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 22365-012-12?

    The NDC Packaged Code 22365-012-12 is assigned to an UNFINISHED drug package of 25 kg in 1 drum of Ursodiol, a bulk ingredient labeled by Arch Pharmalabs Limited. The product's dosage form is powder and is administered via form.

    Is NDC 22365-012 included in the NDC Directory?

    Yes, Ursodiol is an UNFINISHED PRODUCT with code 22365-012 that is active and included in the NDC Directory. The product was first marketed by Arch Pharmalabs Limited on December 17, 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 22365-012-12?

    The 11-digit format is 22365001212. 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
    5-3-222365-012-125-4-222365-0012-12