Ciclopirox
NDC Package 52565-032-12

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 inactivated by the FDA.

Ciclopirox is a medication used to treat fungal infections of the fingernails and toenails. Marketed by Teligent Pharma, Inc., this product is identified by NDC 52565-032 and is authorized under FDA application ANDA209975.

Identification & Billing

NDC Package Code
52565-032-12
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 120 mL in 1 BOTTLE, PLASTIC
Product Code
52565-032
11-Digit Billing Format
52565003212
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ciclopirox
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
Teligent Pharma, Inc.
FDA Application #
ANDA209975
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-05-2018
Listing Expiration
12-31-2022
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 52565-032-12 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 120 ml in 1 bottle, plastic of Ciclopirox, labeled by Teligent Pharma, 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 Teligent Pharma, Inc. on April 05, 2018. The current certification is valid through December 31, 2022.

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 Teligent Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52565003212. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
52565-032-12
11-Digit CMS (5-4-2)
52565-0032-12

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