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  5. NDC Package Code: 68712-027-03 Cnl8

NDC Package 68712-027-03 Cnl8

View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68712-027-03
Package Description:
5 mL in 1 BOTTLE, GLASS
Product Code:
68712-027
Proprietary Name:
Cnl8
Usage Information:
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.)CNL8 (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 Tricho-phyto rubrum. 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. CNL8 (ciclopirox topical solution, 8%) nail lacquer should be used only under medical supervision as described above.  The effectiveness and safety of CNL8 (ciclopirox topical solution, 8%) nail lacquer in the following populations have not been studied. The clinical trials with use of CNL8 (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 derma-tomycoses, 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 CNL8 (ciclopirox topical solution, 8%) nail lacquer daily for greater than 48 weeks have not been established.
11-Digit NDC Billing Format:
68712002703
NDC to RxNorm Crosswalk:
Labeler Name:
Innocutis Holdings Llc
Sample Package:
No
FDA Application Number:
ANDA078270
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
10-31-2008
Listing Expiration Date:
12-31-2017
Exclude Flag:
I
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
68712-027-013 BOTTLE, GLASS in 1 CARTON / 5 mL in 1 BOTTLE, GLASS (68712-027-03)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 68712-027-03?

The NDC Packaged Code 68712-027-03 is assigned to a package of 5 ml in 1 bottle, glass of Cnl8, labeled by Innocutis Holdings Llc. The product's dosage form is and is administered via form.

Is NDC 68712-027 included in the NDC Directory?

No, Cnl8 with product code 68712-027 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Innocutis Holdings Llc on October 31, 2008 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 68712-027-03?

The 11-digit format is 68712002703. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-268712-027-035-4-268712-0027-03