Ursodiol (process Iv) Powder
NDC Package 70294-103-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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.

Ursodiol (process Iv) powders is 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). This formulation utilizes a powder delivery system. Marketed by Daewoong Bio Inc., this product is identified by NDC 70294-103.

Identification & Billing

NDC Package Code
70294-103-02
Package Description
25 kg in 1 DRUM
Product Code
70294-103
11-Digit Billing Format
70294010302

Clinical Specifications

Proprietary Name
Ursodiol (process Iv)
Non-Proprietary Name
Ursodiol (process Iv)
Substance Name
Ursodiol
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
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.

Regulatory & Marketing

Labeler Name
Daewoong Bio Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date
02-07-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70294-103-02 identifies a specific commercial package of 25 kg in 1 drum of Ursodiol (process Iv) (UNFINISHED drug), a bulk ingredient labeled by Daewoong Bio Inc.. This powder is formulated for use and contains ursodiol as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Daewoong Bio Inc. on February 07, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Daewoong Bio Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70294010302. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70294-103-02
11-Digit CMS (5-4-2)
70294-0103-02

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.