Premier Value Antifungal Liquid
NDC Package 68016-474-00

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

Package Information

Premier Value Antifungal (undecylenic acid) liquids is read all warnings and directions. This formulation utilizes a liquid delivery system. Marketed by Pharmacy Value Alliance, Llc, this product is identified by NDC 68016-474 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
68016-474-00
Package Description
30 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
68016-474
11-Digit Billing Format
68016047400
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML

Clinical Specifications

Proprietary Name
Premier Value Antifungal Maximum Strength
Non-Proprietary Name
Undecylenic Acid
Substance Name
Undecylenic Acid
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
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 mg/30mL
Usage Information
Read all warnings and directions. ▪Read all package directions and warnings before use▪Use only as directed▪clean the affected area with soap and warm water and dry thoroughly▪Apply a thin layer of this product over affected area twice daily (morning and night) or as directed by a doctor.▪The brush applicator allows for easy application under nails and surrounding cuticle area.▪wear well-fitting, ventilated shoes, and change shoes and socks at least once daily▪this product is not effective on the scalp or nails▪for athlete's foot: pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.▪For athlete's foot and ringworm, use daily for 4 weeks. If conditions persists longer, consult a doctor ▪Intended for use by normally healthy adults only▪Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor▪Supervise children in the use of this product

Regulatory & Marketing

Labeler Name
Pharmacy Value Alliance, Llc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-10-2019
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 68016-474-00 identifies a specific commercial package of 30 ml in 1 bottle, with applicator of Premier Value Antifungal Maximum Strength, a human over the counter drug labeled by Pharmacy Value Alliance, Llc. This product is billed per "ML" milliliter and contains an estimated amount of 30 billable units per package. This liquid 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 Pharmacy Value Alliance, Llc on April 10, 2019. The current certification is valid through December 31, 2026.

How is this Pharmacy Value Alliance, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68016047400. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 30 total billable units per package. 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)
68016-474-00
11-Digit CMS (5-4-2)
68016-0474-00

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