Diclogen Kit
NDC Package 59088-802-00

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

Package Information

Diclogen (diclofenac sodium, camphor and menthol) kits is diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). This formulation utilizes a kit delivery system. Marketed by Puretek Corporation, this product is identified by NDC 59088-802.

Identification & Billing

NDC Package Code
59088-802-00
Package Description
1 KIT in 1 KIT * 1 BOTTLE, DROPPER in 1 CARTON (59088-435-10) / 150 mL in 1 BOTTLE, DROPPER * 85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07)
Product Code
59088-802
11-Digit Billing Format
59088080200
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diclogen
Non-Proprietary Name
Diclofenac Sodium, Camphor And Menthol
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1).

Regulatory & Marketing

Labeler Name
Puretek Corporation
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
07-26-2024
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 59088-802-00 identifies a specific commercial package of 1 kit in 1 kit * 1 bottle, dropper in 1 carton (59088-435-10) / 150 ml in 1 bottle, dropper * 85 g in 1 bottle, with applicator (59088-283-07) of Diclogen, a human prescription drug labeled by Puretek Corporation. This kit is formulated for use and contains 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 Puretek Corporation on July 26, 2024. The current certification is valid through December 31, 2026.

How is this Puretek Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59088080200. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
59088-802-00
11-Digit CMS (5-4-2)
59088-0802-00

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