Febuxostat Tablet, Film Coated
NDC Package 16714-059-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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, film coated delivery system. Marketed by Northstar Rxllc, this product is identified by NDC 16714-059 and is authorized under FDA application ANDA205467.

Identification & Billing

NDC Package Code
16714-059-01
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
16714-059
11-Digit Billing Format
16714005901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Febuxostat
Non-Proprietary Name
Febuxostat
Substance Name
Febuxostat
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
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
Northstar Rxllc
Product Type
Human Prescription Drug
FDA Application #
ANDA205467
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-26-2021
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 16714-059-01 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Febuxostat, a human prescription drug labeled by Northstar Rxllc. This tablet, film coated 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 Northstar Rxllc on January 26, 2021. 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 Northstar Rxllc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16714005901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
16714-059-01
11-Digit CMS (5-4-2)
16714-0059-01

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