Ursodiol 200 Mg
NDC Package 0722-7143-01

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 inactivated by the FDA.

Ursodiol 200 Mg is 1.Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Marketed by Nexgen Pharma, Inc, this product is identified by NDC 0722-7143 and is authorized under FDA application ANDA205789.

Identification & Billing

NDC Package Code
0722-7143-01
Package Description
100 CAPSULE in 1 BOTTLE
Product Code
0722-7143
11-Digit Billing Format
00722714301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ursodiol 200 Mg
Dosage Form
-
Usage Information
1.Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established.2.Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

Regulatory & Marketing

Labeler Name
Nexgen Pharma, Inc
FDA Application #
ANDA205789
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2020
Listing Expiration
12-31-2021
Exclude Flag
I
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 0722-7143-01 identifies a specific commercial package of 100 capsule in 1 bottle of Ursodiol 200 Mg, labeled by Nexgen Pharma, Inc. 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 Nexgen Pharma, Inc on July 01, 2020. The current certification is valid through December 31, 2021.

How is this Nexgen Pharma, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00722714301. 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)
0722-7143-01
11-Digit CMS (5-4-2)
00722-7143-01

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