Efinaconazole Powder, For Solution
NDC Package 68259-1314-2

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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.

Efinaconazole powders is a medication used to treat toenail infection caused by fungus. This formulation utilizes a powder, for solution delivery system. Marketed by Sumitomo Chemical Company, Limited, this product is identified by NDC 68259-1314.

Identification & Billing

NDC Package Code
68259-1314-2
Package Description
30 kg in 1 DRUM
Product Code
68259-1314
11-Digit Billing Format
68259131402

Clinical Specifications

Proprietary Name
Efinaconazole
Non-Proprietary Name
Efinaconazole
Substance Name
Efinaconazole
Dosage Form
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Active Ingredient(s)
EFINACONAZOLE 1 kg/kg
Usage Information
This medication is used to treat toenail infection caused by fungus. It works by stopping the growth of certain types of fungus. Efinaconazole belongs to a class of drugs known as azole antifungals. This medication treats only fungal infections. It will not work for other types of infection, such as those caused by bacteria. Unnecessary use or overuse of any drug used to treat infection can lead to its decreased effectiveness.

Regulatory & Marketing

Labeler Name
Sumitomo Chemical Company, Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-20-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68259-1314). Click a package code to view its specific billing and regulatory data.

68259-1314-1
30 kg in 1 BAG

* 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 68259-1314-2 identifies a specific commercial package of 30 kg in 1 drum of Efinaconazole (UNFINISHED drug), a bulk ingredient labeled by Sumitomo Chemical Company, Limited. This powder, for solution is formulated for use and contains efinaconazole 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 Sumitomo Chemical Company, Limited on July 20, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat toenail infection caused by fungus. It works by stopping the growth of certain types of fungus. Efinaconazole belongs to a class of drugs known as azole antifungals. This medication treats only fungal infections. It will not work for other types of infection, such as those caused by bacteria. Unnecessary use or overuse of any drug used to treat infection can lead to its decreased effectiveness.

How is this Sumitomo Chemical Company, Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68259131402. 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 (5-4-1)
68259-1314-2
11-Digit CMS (5-4-2)
68259-1314-02

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