Nail Renewal
NDC Package 83619-003-01

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.

Nail Renewal is spread the product over the nail fungus and walt for the product to be absorbed. Marketed by Shenzhen Derbit Technology Co., Ltd., this product is identified by NDC 83619-003 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
83619-003-01
Package Description
30 mL in 1 BOTTLE
Product Code
83619-003
11-Digit Billing Format
83619000301

Clinical Specifications

Proprietary Name
Nail Renewal
Dosage Form
-
Usage Information
Spread the product over the nail fungus and walt for the product to be absorbed. When using this product, supervise children under 6 years of age to avoid swallowing.

Regulatory & Marketing

Labeler Name
Shenzhen Derbit Technology Co., Ltd.
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-08-2024
Listing Expiration
12-31-2025
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 83619-003-01 identifies a specific commercial package of 30 ml in 1 bottle of Nail Renewal, labeled by Shenzhen Derbit Technology Co., Ltd.. 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 Shenzhen Derbit Technology Co., Ltd. on May 08, 2024. The current certification is valid through December 31, 2025.

How is this Shenzhen Derbit Technology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83619000301. 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)
83619-003-01
11-Digit CMS (5-4-2)
83619-0003-01

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