Fungazoil Advanced
NDC Package 68927-3492-1

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.

Fungazoil Advanced is read all package directions and warnings before using.• Use only as directed.• Clean the affected area with soap and warm water and dry thoroughly.• Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor.• This product is not effective on the scalp or nails.• Avoid applying to severely cracked or irritated areas.• For athlete’s foot: pay special attention to spaces between toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.• For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.• Super vise children in the use of this product.• Intended for use by normally healthy adults only.• Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.Other InformationApply to skin around affected areas. Marketed by Pedifix, this product is identified by NDC 68927-3492 and is authorized under FDA application part333C.

Identification & Billing

NDC Package Code
68927-3492-1
Package Description
15 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
68927-3492
11-Digit Billing Format
68927349201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fungazoil Advanced
Dosage Form
-
Usage Information
Read all package directions and warnings before using.• Use only as directed.• Clean the affected area with soap and warm water and dry thoroughly.• Apply a thin layer over the affected area twice daily (morning and night) or as directed by a doctor.• This product is not effective on the scalp or nails.• Avoid applying to severely cracked or irritated areas.• For athlete’s foot: pay special attention to spaces between toes, wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.• For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.• Super vise children in the use of this product.• Intended for use by normally healthy adults only.• Persons under 18 years of age or those with sensitive or allergic skin should use only as directed by a doctor.Other InformationApply to skin around affected areas. While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use until satisfactory results are obtained.

Regulatory & Marketing

Labeler Name
Pedifix
FDA Application #
part333C
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
06-15-2014
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 68927-3492-1 identifies a specific commercial package of 15 ml in 1 bottle, with applicator of Fungazoil Advanced, labeled by Pedifix. 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 Pedifix on June 15, 2014. The current certification is valid through December 31, 2017.

How is this Pedifix product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68927349201. 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)
68927-3492-1
11-Digit CMS (5-4-2)
68927-3492-01

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