NDC Package 63629-2287-1 Ursodiol

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

Package Information
Frequently Asked Questions

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:

63629-2287-1

Package Description:

100 TABLET, FILM COATED in 1 BOTTLE

Product Code:

63629-2287

Proprietary Name:

Ursodiol

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:

63629228701

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

100 EA

NDC to RxNorm Crosswalk:

RxCUI: 858733 - ursodiol 500 MG Oral Tablet

Product Type:

Human Prescription Drug

Labeler Name:

Bryant Ranch Prepack

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:

FDA Application Number:

ANDA202540

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

08-01-2013

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

63629 - Bryant Ranch Prepack
- 63629-2287 - Ursodiol
  - 63629-2287-1 - 100 TABLET, FILM COATED in 1 BOTTLE

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 63629-2287-1?

The NDC Packaged Code 63629-2287-1 is assigned to a package of 100 tablet, film coated in 1 bottle of Ursodiol, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is tablet, film coated and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package.

Is NDC 63629-2287 included in the NDC Directory?

Yes, Ursodiol with product code 63629-2287 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on August 01, 2013 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 NDC billing unit for package 63629-2287-1?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

What is the 11-digit format for NDC 63629-2287-1?

The 11-digit format is 63629228701. 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 5-4-1 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
5-4-1	63629-2287-1	5-4-2	63629-2287-01

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