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  5. NDC Package Code: 85308-002-01 Fungal Nail Treatment

NDC Package 85308-002-01 Fungal Nail Treatment

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:
85308-002-01
Package Description:
30 mL in 1 BOTTLE
Product Code:
85308-002
Proprietary Name:
Fungal Nail Treatment
Non-Proprietary Name:
Fungal Nail Treatment
Substance Name:
Undecylenic Acid
Usage Information:
Directions 1. Apply the product twice a day, in the morning and at night. 2.For initial use, soak the affected nail in warm water to soften it. Gently file thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days. 3. Hold the bottle at an angle to pour 2-3 drops.Use the brush applicator to applythe solution on the affected areas. 4. For best results, use this product consistenthy for 3-6 months, as fungal nail infections require prolonged treatment. Visible improvements may appear in as little as 7 days, but complete healing takes longer.
11-Digit NDC Billing Format:
85308000201
NDC to RxNorm Crosswalk:
Product Type:
Human Otc Drug
Labeler Name:
Gaoye Marketing Inc
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:
04-03-2025
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 85308-002-01?

The NDC Packaged Code 85308-002-01 is assigned to a package of 30 ml in 1 bottle of Fungal Nail Treatment, a human over the counter drug labeled by Gaoye Marketing Inc. The product's dosage form is liquid and is administered via topical form.

Is NDC 85308-002 included in the NDC Directory?

Yes, Fungal Nail Treatment with product code 85308-002 is active and included in the NDC Directory. The product was first marketed by Gaoye Marketing Inc on April 03, 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 85308-002-01?

The 11-digit format is 85308000201. 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
5-3-285308-002-015-4-285308-0002-01