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  5. NDC Package Code: 59285-028-01 Obeticholic Acid

NDC Package 59285-028-01 Obeticholic Acid

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:
59285-028-01
Package Description:
50 kg in 1 DRUM
Product Code:
59285-028
Non-Proprietary Name:
Obeticholic Acid
Substance Name:
Obeticholic Acid
Usage Information:
This medication is used alone or in combination treatment for a certain liver disease (primary biliary cholangitis-PBC). This disease slowly destroys the bile ducts in the liver. When bile ducts are damaged, harmful substances can build up in bile and scar the liver. Obeticholic acid works by causing your liver to make less bile, and by helping bile flow out of the liver. Obeticholic acid may help slow worsening of primary biliary cholangitis and decrease symptoms such as tiredness, itchy skin, abdominal pain, and dry eyes and mouth.
11-Digit NDC Billing Format:
59285002801
Product Type:
Bulk Ingredient
Labeler Name:
Optimus Drugs Private 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):
  • OBETICHOLIC ACID 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:
    12-26-2019
    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 59285-028-01?

    The NDC Packaged Code 59285-028-01 is assigned to an UNFINISHED drug package of 50 kg in 1 drum of Obeticholic Acid, a bulk ingredient labeled by Optimus Drugs Private Limited. The product's dosage form is powder and is administered via form.

    Is NDC 59285-028 included in the NDC Directory?

    Yes, Obeticholic Acid is an UNFINISHED PRODUCT with code 59285-028 that is active and included in the NDC Directory. The product was first marketed by Optimus Drugs Private Limited on December 26, 2019 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 59285-028-01?

    The 11-digit format is 59285002801. 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
    5-3-259285-028-015-4-259285-0028-01