Febuxostat Tablet
NDC Package 55111-796-01

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

Febuxostat tablets is febuxostat is used to lower uric acid levels in people with gout. This formulation utilizes a tablet delivery system. Marketed by Dr Reddy's Laboratories Limited, this product is identified by NDC 55111-796 and is authorized under FDA application ANDA205374.

Identification & Billing

NDC Package Code
55111-796-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
55111-796
11-Digit Billing Format
55111079601
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Febuxostat
Non-Proprietary Name
Febuxostat
Substance Name
Febuxostat
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FEBUXOSTAT 40 mg/1
Pharmacologic Class
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
Dr Reddy's Laboratories Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA205374
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-25-2020
Listing Expiration
12-31-2026
Exclude Flag
N
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 (55111-796). Click a package code to view its specific billing and regulatory data.

55111-796-05
500 TABLET in 1 BOTTLE
55111-796-30
30 TABLET in 1 BOTTLE
55111-796-90
90 TABLET 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 55111-796-01 identifies a specific commercial package of 100 tablet in 1 bottle of Febuxostat, a human prescription drug labeled by Dr Reddy's Laboratories Limited. This tablet is formulated for oral use and contains febuxostat as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Dr Reddy's Laboratories Limited on November 25, 2020. The current certification is valid through December 31, 2026.

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 Dr Reddy's Laboratories Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55111079601. 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)
55111-796-01
11-Digit CMS (5-4-2)
55111-0796-01

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