Febuxostat
NDC Package 48792-7906-1

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.

Febuxostat is used to lower uric acid levels in people with gout. Marketed by Sunshine Lake Pharma Co., Ltd., this product is identified by NDC 48792-7906 and is authorized under FDA application ANDA213069.

Identification & Billing

NDC Package Code
48792-7906-1
Package Description
30 TABLET in 1 BOTTLE
Product Code
48792-7906
11-Digit Billing Format
48792790601

Clinical Specifications

Proprietary Name
Febuxostat
Dosage Form
-
Usage Information
Febuxostat is used to lower uric acid levels in people with gout. Febuxostat works by reducing the amount of uric acid made by the body. An increased uric acid level can cause gout. Because of the risk of very serious heart-related problems and stroke with febuxostat (see also Warning section), febuxostat should be used only after treatment with a medication called allopurinol did not work to lower your uric acid level, caused serious side effects, or is not recommended by your doctor. Febuxostat should be used only if you have symptoms caused by a high blood uric acid level.

Regulatory & Marketing

Labeler Name
Sunshine Lake Pharma Co., Ltd.
FDA Application #
ANDA213069
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-02-2020
End Marketing Date
06-02-2020
Listing Expiration
06-02-2020
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 48792-7906-1 identifies a specific commercial package of 30 tablet in 1 bottle of Febuxostat, labeled by Sunshine Lake Pharma Co., Ltd.. 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 Sunshine Lake Pharma Co., Ltd. on June 02, 2020. The current certification is valid through June 02, 2020.

What are the primary indications for this medication?

Febuxostat is used to lower uric acid levels in people with gout. Febuxostat works by reducing the amount of uric acid made by the body. An increased uric acid level can cause gout. Because of the risk of very serious heart-related problems and stroke with febuxostat (see also Warning section), febuxostat should be used only after treatment with a medication called allopurinol did not work to lower your uric acid level, caused serious side effects, or is not recommended by your doctor. Febuxostat should be used only if you have symptoms caused by a high blood uric acid level.

How is this Sunshine Lake Pharma Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48792790601. 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 (5-4-1)
48792-7906-1
11-Digit CMS (5-4-2)
48792-7906-01

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