NDC Package 58914-790-01 Urso Forte

Ursodiol Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

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Package Information

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:

58914-790-01

Package Description:

4 TABLET, FILM COATED in 1 BLISTER PACK

Product Code:

58914-790

Proprietary Name:

Urso Forte

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:

58914079001

NDC to RxNorm Crosswalk:

RxCUI: 858733 - ursodiol 500 MG Oral Tablet

RxCUI: 858735 - Urso Forte 500 MG Oral Tablet

RxCUI: 858735 - ursodiol 500 MG Oral Tablet [Urso Forte]

RxCUI: 858751 - ursodiol 250 MG Oral Tablet

RxCUI: 858752 - Urso-250 250 MG Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Allergan, Inc.

Dosage Form:

Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

URSODIOL 500 mg/1

Pharmacologic Class(es):

Bile Acid - [EPC] (Established Pharmacologic Class)

Bile Acids and Salts - [CS]

Sample Package:

Yes

FDA Application Number:

NDA020675

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

12-10-1997

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

58914 - Allergan, Inc.
- 58914-790 - Urso Forte
  - 58914-790-01 - 4 TABLET, FILM COATED in 1 BLISTER PACK

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
58914-790-10	100 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 58914-790-01?

The NDC Packaged Code 58914-790-01 is assigned to a package of 4 tablet, film coated in 1 blister pack of Urso Forte, a human prescription drug labeled by Allergan, Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 58914-790 included in the NDC Directory?

Yes, Urso Forte with product code 58914-790 is active and included in the NDC Directory. The product was first marketed by Allergan, Inc. on December 10, 1997 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 58914-790-01?

The 11-digit format is 58914079001. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	58914-790-01	5-4-2	58914-0790-01

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