Ursodiol
NDC Package 0115-9934-01

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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). Marketed by Impax Generics, this product is identified by NDC 0115-9934 and is authorized under FDA application ANDA200826.

Identification & Billing

NDC Package Code
0115-9934-01
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
0115-9934
11-Digit Billing Format
00115993401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA

Clinical Specifications

Proprietary Name
Ursodiol
Dosage Form
-
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
Impax Generics
FDA Application #
ANDA200826
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-23-2011
End Marketing Date
08-31-2020
Listing Expiration
08-31-2020
Exclude Flag
D
Sample Package
No

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 0115-9934-01 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Ursodiol, labeled by Impax Generics. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Impax Generics on December 23, 2011. The current certification is valid through August 31, 2020.

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 Impax Generics product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00115993401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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 (4-4-2)
0115-9934-01
11-Digit CMS (5-4-2)
00115-9934-01

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