Gold Mountain Beauty Fungal Nail Eliminator
NDC Package 76348-417-02

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.

Gold Mountain Beauty Fungal Nail Eliminator is trim nails and file the surface using an emery board Apply a thin layer of product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around nails Allow solution to soak into nail or skin Application to adjacent nails is recommended to prevent the spread of infection Keep affected areas clean and dry throughout the day Supervise children in the use of this product. Marketed by Renu Laboratories, Inc., this product is identified by NDC 76348-417 and is authorized under FDA application part333C.

Identification & Billing

NDC Package Code
76348-417-02
Package Description
1 BOTTLE, GLASS in 1 BOX / 14 g in 1 BOTTLE, GLASS (76348-417-01)
Product Code
76348-417
11-Digit Billing Format
76348041702
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gold Mountain Beauty Fungal Nail Eliminator
Dosage Form
-
Usage Information
Trim nails and file the surface using an emery board Apply a thin layer of product over affected areas twice daily (morning and night) especially around free edges of nails (under tips) and cuticles and the space around nails Allow solution to soak into nail or skin Application to adjacent nails is recommended to prevent the spread of infection Keep affected areas clean and dry throughout the day Supervise children in the use of this product

Regulatory & Marketing

Labeler Name
Renu Laboratories, Inc.
FDA Application #
part333C
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
07-02-2018
Listing Expiration
12-31-2023
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 76348-417-02 identifies a specific commercial package of 1 bottle, glass in 1 box / 14 g in 1 bottle, glass (76348-417-01) of Gold Mountain Beauty Fungal Nail Eliminator, labeled by Renu Laboratories, 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 Renu Laboratories, Inc. on July 02, 2018. The current certification is valid through December 31, 2023.

How is this Renu Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76348041702. 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)
76348-417-02
11-Digit CMS (5-4-2)
76348-0417-02

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