Tolnaftate Suspension
NDC Package 49354-080-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Tolnaftate suspension is tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. This formulation utilizes a suspension delivery system. Marketed by Hk Kolmar Canada, Inc, this product is identified by NDC 49354-080.

Identification & Billing

NDC Package Code
49354-080-01
Package Description
126 BOTTLE, WITH APPLICATOR in 1 BOX / 30 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
49354-080
11-Digit Billing Format
49354008001

Clinical Specifications

Proprietary Name
Tolnaftate
Non-Proprietary Name
Tolnaftate
Substance Name
Tolnaftate
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Active Ingredient(s)
TOLNAFTATE 10 mg/mL
Usage Information
Tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. It is an antifungal that works by preventing the growth of fungus.

Regulatory & Marketing

Labeler Name
Hk Kolmar Canada, Inc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
01-11-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 49354-080-01 identifies a specific commercial package of 126 bottle, with applicator in 1 box / 30 ml in 1 bottle, with applicator of Tolnaftate (UNFINISHED drug), drug for further processing labeled by Hk Kolmar Canada, Inc. This suspension is formulated for use and contains tolnaftate 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 Hk Kolmar Canada, Inc on January 11, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Tolnaftate is used to treat skin infections such as athlete's foot, jock itch, and ringworm. It is an antifungal that works by preventing the growth of fungus.

How is this Hk Kolmar Canada, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49354008001. 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)
49354-080-01
11-Digit CMS (5-4-2)
49354-0080-01

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