NDC Package 64980-483-01 Ursodiol

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

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

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:

64980-483-01

Package Description:

100 CAPSULE in 1 BOTTLE

Product Code:

64980-483

Proprietary 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:

64980048301

Labeler Name:

Rising Pharma Holdings, Inc.

Sample Package:

FDA Application Number:

ANDA213200

Marketing Category:

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

Start Marketing Date:

02-12-2020

End Marketing Date:

02-13-2020

Listing Expiration Date:

02-13-2020

Exclude Flag:

Code Structure:

64980 - Rising Pharma Holdings, Inc.
- 64980-483 - Ursodiol
  - 64980-483-01 - 100 CAPSULE 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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
64980-483-03	30 CAPSULE in 1 BOTTLE
64980-483-50	500 CAPSULE in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 64980-483-01?

The NDC Packaged Code 64980-483-01 is assigned to a package of 100 capsule in 1 bottle of Ursodiol, labeled by Rising Pharma Holdings, Inc.. The product's dosage form is and is administered via form.

Is NDC 64980-483 included in the NDC Directory?

No, Ursodiol with product code 64980-483 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Rising Pharma Holdings, Inc. on February 12, 2020 and its listing in the NDC Directory is set to expire on February 13, 2020 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 64980-483-01?

The 11-digit format is 64980048301. 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	64980-483-01	5-4-2	64980-0483-01

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