Undesine
NDC Package 10578-009-01

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Undesine is uses:cures athletes foot (dermatophytosis)clears up ringworm (tinea corporis)cures jock itch (tinea cruris). Marketed by Indiana Botanic Gardens, this product is identified by NDC 10578-009 and is authorized under FDA application part333C.

Identification & Billing

NDC Package Code
10578-009-01
Package Description
29 g in 1 JAR
Product Code
10578-009
11-Digit Billing Format
10578000901
RxNorm Crosswalk
  • RxCUI: 313552 - undecylenic acid 5 % / zinc undecylenate 20 % Topical Ointment
  • RxCUI: 313552 - undecylenic acid 0.05 MG/MG / zinc undecylenate 0.2 MG/MG Topical Ointment

Clinical Specifications

Proprietary Name
Undesine
Dosage Form
-
Usage Information
Uses:cures athletes foot (dermatophytosis)clears up ringworm (tinea corporis)cures jock itch (tinea cruris)

Regulatory & Marketing

Labeler Name
Indiana Botanic Gardens
FDA Application #
part333C
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
01-01-1995
Listing Expiration
12-31-2017
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 10578-009-01 identifies a specific commercial package of 29 g in 1 jar of Undesine, labeled by Indiana Botanic Gardens. 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 Indiana Botanic Gardens on January 01, 1995. The current certification is valid through December 31, 2017.

How is this Indiana Botanic Gardens product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 10578000901. 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)
10578-009-01
11-Digit CMS (5-4-2)
10578-0009-01

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