Quality Choice Tolnaftate Antifungal
NDC Package 63868-104-46

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.

Quality Choice Tolnaftate Antifungal is directionswash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) or as directed by a doctorsupervise children in the use of this product for athlete's foot, pay special attention to space between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least one dailyuse daily for 4 weeks; if condition persists longer, ask a doctorfor athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks. Marketed by Chain Drug Marketing Association Inc, this product is identified by NDC 63868-104 and is authorized under FDA application part333C.

Identification & Billing

NDC Package Code
63868-104-46
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
63868-104
11-Digit Billing Format
63868010446
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
30 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Quality Choice Tolnaftate Antifungal
Dosage Form
-
Usage Information
Directionswash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) or as directed by a doctorsupervise children in the use of this product for athlete's foot, pay special attention to space between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least one dailyuse daily for 4 weeks; if condition persists longer, ask a doctorfor athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks. If condition persists longer consult a doctorthis product is not effective on the scalp or nails

Regulatory & Marketing

Labeler Name
Chain Drug Marketing Association Inc
FDA Application #
part333C
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
05-31-2013
Listing Expiration
12-31-2021
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 63868-104-46 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Quality Choice Tolnaftate Antifungal, labeled by Chain Drug Marketing Association Inc. 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 Chain Drug Marketing Association Inc on May 31, 2013. The current certification is valid through December 31, 2021.

How is this Chain Drug Marketing Association Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63868010446. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. 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)
63868-104-46
11-Digit CMS (5-4-2)
63868-0104-46

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