Ciclopirox
NDC Package 54868-6064-0

11-digit billing NDC: 54868606400 · Billing unit: ML · 6.6 ML per package
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 (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)Ciclopirox topical solution, 8% (nail lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophytonrubrum. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-6064 and is authorized under FDA application ANDA078079.

Identification & Billing

NDC Package Code
54868-6064-0
Package Description
6.6 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
54868-6064
11-Digit Billing Format
54868606400
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
6.6 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ciclopirox
Dosage Form
-
Usage Information
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)Ciclopirox topical solution, 8% (nail lacquer), as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophytonrubrum. The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures.No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended.Ciclopirox topical solution, 8% (nail lacquer), should be used only under medical supervision as described above.The effectiveness and safety of ciclopirox topical solution, 8% (nail lacquer), in the following populations has not been studied. The clinical trials with use of ciclopirox topical solution, 8% (nail lacquer), excluded patients who: were pregnant or nursing, planned to become pregnant, had a history of immunosuppression (e.g., extensive, persistent, or unusual distribution of dermatomycoses, extensive seborrheic dermatitis, recent or recurring herpes zoster, or persistent herpes simplex), were HIV seropositive, received organ transplant, required medication to control epilepsy, were insulin dependent diabetics or had diabetic neuropathy. Patients with severe plantar (moccasin) tinea pedis were also excluded.The safety and efficacy of using ciclopirox topical solution, 8% (nail lacquer), daily for greater than 48 weeks have not been established.Clinical Trials DataThe results of use of ciclopirox topical solution, 8% (nail lacquer), in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the US. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% (nail lacquer) in conjunction with monthly removal of the unattached, infected toenail by the investigator. Ciclopirox topical solution, 8% (nail lacquer), was applied for 48 weeks. At baseline, patients had 20 to 65% involvement of the target great toenail plate. Statistical significance was demonstrated in one of two studies for the endpoint “complete cure” (clear nail and negative mycology), and in two studies for the endpoint “almost clear” (≤ 10% nail involvement and negative mycology) at the end of study. These results are presented below.At Week 48 (plus Last Observation Carried Forward) for the Intent-to-Treat (ITT) Population Study 312Study 313ActiveVehicleActiveVehicleCompleteCure*6/110 (5.5%)1/109 (0.9%)10/118 (8.5%)0/117 (0%)AlmostClear**7/107 (6.5%)1/108 (0.9%)14/116 (12%)1/115 (0.9%)NegativeMycologyAlone***30/105 (29%)12/106 (11%)41/115 (36%)10/114 (9%)*   Clear nail and negative mycology**  ≤ 10% nail involvement and negative mycology***   Negative KOH and negative cultureThe summary of reported patient outcomes for the ITT population at 12 weeks following the end of treatment are presented below. Note that post-treatment efficacy assessments were scheduled only for patients who achieved a complete cure.Post-Treatment Week 12 Data for Patients Who Achieved Complete Cure at Week 48Study 312Study 313ActiveVehicleActiveVehicleNumber of Treated Patients112111119118Complete Cure at Week 4861100Post-Treatment Week 12 Outcomes:Patients Missing All Week 12 Assessments2020Patients with Week 12 Assessments4180Complete Cure3140Almost Clear2*11*0Negative Mycology3150*   Four patients (from studies 312 and 313) who were completely cured did not have post-treatment Week 12 planimetry data.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA078079
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-04-2009
Listing Expiration
12-31-2017
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 54868-6064-0 identifies a specific commercial package of 6.6 ml in 1 bottle, with applicator of Ciclopirox, labeled by Physicians Total Care, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 6.6 billable units per package. 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 Physicians Total Care, Inc. on September 04, 2009. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868606400. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 6.6 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 (5-4-1)
54868-6064-0
11-Digit CMS (5-4-2)
54868-6064-00

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