Auranofin Capsule
NDC Package 85437-093-06

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Auranofin capsules is a medication used as part of a complete treatment program including non-drug therapies (e.g., rest, physical therapy) to treat active rheumatoid arthritis. This formulation utilizes a capsule delivery system. Marketed by Coral Way Pharma, Llc, this product is identified by NDC 85437-093 and is authorized under FDA application NDA018689.

Identification & Billing

NDC Package Code
85437-093-06
Package Description
60 CAPSULE in 1 BOTTLE
Product Code
85437-093
11-Digit Billing Format
85437009306
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
60 EA
RxNorm Crosswalk
RxCUI: 197386 - auranofin 3 MG Oral Capsule

Clinical Specifications

Proprietary Name
Auranofin
Non-Proprietary Name
Auranofin
Substance Name
Auranofin
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
AURANOFIN 3 mg/1
Usage Information
This medication is used as part of a complete treatment program including non-drug therapies (e.g., rest, physical therapy) to treat active rheumatoid arthritis. It is used to treat patients with severe rheumatoid arthritis who have not responded to or cannot take other medications. Auranofin is a gold compound. Auranofin is not a true pain reliever (e.g., like aspirin) but it is thought to decrease pain that occurs with arthritis by decreasing inflammation. It is known as a disease-modifying antirheumatic drug (DMARD). It decreases morning stiffness and pain/swelling in joints and can increase grip strength.

Regulatory & Marketing

Labeler Name
Coral Way Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA018689
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
10-29-2025
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 85437-093-06 identifies a specific commercial package of 60 capsule in 1 bottle of Auranofin, a human prescription drug labeled by Coral Way Pharma, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 60 billable units per package. This capsule is formulated for oral use and contains auranofin 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 Coral Way Pharma, Llc on October 29, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used as part of a complete treatment program including non-drug therapies (e.g., rest, physical therapy) to treat active rheumatoid arthritis. It is used to treat patients with severe rheumatoid arthritis who have not responded to or cannot take other medications. Auranofin is a gold compound. Auranofin is not a true pain reliever (e.g., like aspirin) but it is thought to decrease pain that occurs with arthritis by decreasing inflammation. It is known as a disease-modifying antirheumatic drug (DMARD). It decreases morning stiffness and pain/swelling in joints and can increase grip strength.

How is this Coral Way Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85437009306. 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)
85437-093-06
11-Digit CMS (5-4-2)
85437-0093-06

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