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  5. NDC Package Code: 85578-003-01 Tegasolve Toenail Fungus Treatment

NDC Package 85578-003-01 Tegasolve Toenail Fungus Treatment

Undecylenic Acid 25% Liquid Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
85578-003-01
Package Description:
1 BOTTLE in 1 BOX / 30 mL in 1 BOTTLE
Product Code:
85578-003
Proprietary Name:
Tegasolve Toenail Fungus Treatment
Non-Proprietary Name:
Undecylenic Acid 25%
Substance Name:
Undecylenic Acid
Usage Information:
For the effective treatment of most nail fungus, athlete's foot, ringworm, andother skin fungus infections Helps relieve symptoms such as discoloration, brittleness, thickened orcrumbling nails
11-Digit NDC Billing Format:
85578000301
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Zhengzhou Hangrui Network Technology Co., Ltd.
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s):
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s):
UNDECYLENIC ACID 25 g/100mL
Sample Package:
No
FDA Application Number:
M005
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
06-12-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
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.

Frequently Asked Questions

What is NDC 85578-003-01?

The NDC Packaged Code 85578-003-01 is assigned to a package of 1 bottle in 1 box / 30 ml in 1 bottle of Tegasolve Toenail Fungus Treatment, a human over the counter drug labeled by Zhengzhou Hangrui Network Technology Co., Ltd.. The product's dosage form is liquid and is administered via topical form.

Is NDC 85578-003 included in the NDC Directory?

Yes, Tegasolve Toenail Fungus Treatment with product code 85578-003 is active and included in the NDC Directory. The product was first marketed by Zhengzhou Hangrui Network Technology Co., Ltd. on June 12, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 85578-003-01?

The 11-digit format is 85578000301. 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
5-3-285578-003-015-4-285578-0003-01