Ciclopirox Kit
NDC Package 42192-714-01

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

Package Information

Ciclopirox kits is a medication used to treat fungal infections of the fingernails and toenails. This formulation utilizes a kit delivery system. Marketed by Acella Pharmaceuticals, Llc, this product is identified by NDC 42192-714.

Identification & Billing

NDC Package Code
42192-714-01
Package Description
1 KIT in 1 CARTON * 6.6 mL in 1 BOTTLE, WITH APPLICATOR * 28 mL in 1 BOTTLE
Product Code
42192-714
11-Digit Billing Format
42192071401
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
Non-Proprietary Name
Ciclopirox
Dosage Form
Kit - A packaged collection of related material.
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
Acella Pharmaceuticals, Llc
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
10-10-2011
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 42192-714-01 identifies a specific commercial package of 1 kit in 1 carton * 6.6 ml in 1 bottle, with applicator * 28 ml in 1 bottle of Ciclopirox, a human prescription drug labeled by Acella Pharmaceuticals, Llc. 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 Acella Pharmaceuticals, Llc on October 10, 2011. The current certification is valid through December 31, 2026.

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 Acella Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42192071401. 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)
42192-714-01
11-Digit CMS (5-4-2)
42192-0714-01

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