Ridaura
NDC Package 65483-093-06

11-digit billing NDC: 65483009306 · Billing unit: EA · 60 EA per package
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 inactivated by the FDA.

Ridaura is (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. Marketed by Prometheus Laboratories Inc., this product is identified by NDC 65483-093 and is authorized under FDA application NDA018689.

Identification & Billing

NDC Package Code
65483-093-06
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
65483-093
11-Digit Billing Format
65483009306
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ridaura
Dosage Form
-
Usage Information
RIDAURA (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. RIDAURA should be added to a comprehensive baseline program, including non-drug therapies.Unlike anti-inflammatory drugs, RIDAURA does not produce an immediate response. Therapeutic effects may be seen after three to four months of treatment, although improvement has not been seen in some patients before six months.When cartilage and bone damage has already occurred, gold cannot reverse structural damage to joints caused by previous disease. The greatest potential benefit occurs in patients with active synovitis, particularly in its early stage.In controlled clinical trials comparing RIDAURA with injectable gold, RIDAURA was associated with fewer dropouts due to adverse reactions, while injectable gold was associated with fewer dropouts for inadequate or poor therapeutic effect. Physicians should consider these findings when deciding on the use of RIDAURA in patients who are candidates for chrysotherapy.

Regulatory & Marketing

Labeler Name
Prometheus Laboratories Inc.
FDA Application #
NDA018689
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-24-1985
Listing Expiration
12-31-2017
Exclude Flag
I
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 65483-093-06 identifies a specific commercial package of 60 capsule in 1 bottle of Ridaura, labeled by Prometheus Laboratories Inc.. 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 Prometheus Laboratories Inc. on April 24, 1985. The current certification is valid through December 31, 2017.

How is this Prometheus Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65483009306. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 60 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)
65483-093-06
11-Digit CMS (5-4-2)
65483-0093-06

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