Ciclodan
NDC Package 43538-521-90

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
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 discontinued by the firm.

Ciclodan is a medication used to treat fungal infections of the fingernails and toenails. Marketed by Medimetriks Pharmaceuticals, Inc., this product is identified by NDC 43538-521 and is authorized under FDA application ANDA077364.

Identification & Billing

NDC Package Code
43538-521-90
Package Description
1 KIT in 1 CARTON * 454 g in 1 BOTTLE, PUMP * 90 g in 1 TUBE
Product Code
43538-521
11-Digit Billing Format
43538052190
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.

Clinical Specifications

Proprietary Name
Ciclodan
Dosage Form
-
Usage Information
This medication is used to treat fungal infections of the fingernails and toenails. It is used as part of a treatment program that includes the removal of unattached, infected nails by a health care professional as frequently as once a month. Ciclopirox works by stopping the growth of fungus.

Regulatory & Marketing

Labeler Name
Medimetriks Pharmaceuticals, Inc.
FDA Application #
ANDA077364
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-15-2012
End Marketing Date
12-01-2017
Listing Expiration
12-01-2017
Exclude Flag
D
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 43538-521-90 identifies a specific commercial package of 1 kit in 1 carton * 454 g in 1 bottle, pump * 90 g in 1 tube of Ciclodan, labeled by Medimetriks Pharmaceuticals, 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 Medimetriks Pharmaceuticals, Inc. on June 15, 2012. The current certification is valid through December 01, 2017.

What are the primary indications for this medication?

This medication is used to treat fungal infections of the fingernails and toenails. It is used as part of a treatment program that includes the removal of unattached, infected nails by a health care professional as frequently as once a month. Ciclopirox works by stopping the growth of fungus.

How is this Medimetriks Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43538052190. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
43538-521-90
11-Digit CMS (5-4-2)
43538-0521-90

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