Febuxostat
NDC Package 13668-560-05

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Torrent Pharmaceuticals Limited, this product is identified by NDC 13668-560 and is authorized under FDA application ANDA211837.

Identification & Billing

NDC Package Code
13668-560-05
Package Description
500 TABLET, FILM COATED in 1 BOTTLE
Product Code
13668-560
11-Digit Billing Format
13668056005

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
Torrent Pharmaceuticals Limited
FDA Application #
ANDA211837
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-19-2023
End Marketing Date
12-19-2023
Listing Expiration
12-19-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (13668-560). Click a package code to view its specific billing and regulatory data.

13668-560-30
30 TABLET, FILM COATED in 1 BOTTLE
13668-560-74
10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
13668-560-90
90 TABLET, FILM COATED in 1 BOTTLE

* 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 13668-560-05 identifies a specific commercial package of 500 tablet, film coated in 1 bottle of Febuxostat, labeled by Torrent Pharmaceuticals Limited. 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 Torrent Pharmaceuticals Limited on December 19, 2023. The current certification is valid through December 19, 2023.

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 Torrent Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13668056005. 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 (5-3-2)
13668-560-05
11-Digit CMS (5-4-2)
13668-0560-05

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