Lunavia Antifungal Spray
NDC Package 85210-002-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lunavia Antifungal (undecylenic acid 25%) sprays is ■ Read all warnings and directions.■ Use only as directed.■ Clean the affected area with soap and water and dry thoroughly.■ Remove cap from Bottle.■ Spray the bottle on and inside shoes, socks, and feet until all areas are covered.■ Spray a thin layer of the product over the contaminated area twice daily (morning and night) or as directed by a doctor.■ For athlete's foot, pay special attention to spaces between the toes; wear well-fitting,ventilated shoe, and change shoes and socks at least once daily. This formulation utilizes a spray delivery system. Marketed by Xf Agencija Limited, this product is identified by NDC 85210-002 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85210-002-01
Package Description
1 BOTTLE in 1 BOX / 120 mL in 1 BOTTLE
Product Code
85210-002
11-Digit Billing Format
85210000201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lunavia Antifungal
Non-Proprietary Name
Undecylenic Acid 25%
Substance Name
Undecylenic Acid
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
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
Usage Information
■ Read all warnings and directions.■ Use only as directed.■ Clean the affected area with soap and water and dry thoroughly.■ Remove cap from Bottle.■ Spray the bottle on and inside shoes, socks, and feet until all areas are covered.■ Spray a thin layer of the product over the contaminated area twice daily (morning and night) or as directed by a doctor.■ For athlete's foot, pay special attention to spaces between the toes; wear well-fitting,ventilated shoe, and change shoes and socks at least once daily.

Regulatory & Marketing

Labeler Name
Xf Agencija Limited
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-13-2025
Listing Expiration
12-31-2026
Exclude Flag
N
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 85210-002-01 identifies a specific commercial package of 1 bottle in 1 box / 120 ml in 1 bottle of Lunavia Antifungal, a human over the counter drug labeled by Xf Agencija Limited. This spray is formulated for topical use and contains undecylenic acid as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Xf Agencija Limited on June 13, 2025. The current certification is valid through December 31, 2026.

How is this Xf Agencija Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85210000201. 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)
85210-002-01
11-Digit CMS (5-4-2)
85210-0002-01

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