Selan Antifungal Cream
NDC Package 0159-2500-04

11-digit billing NDC: 00159250004
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Selan Antifungal cream is  - Clean affected area and dry thoroughly - Apply a thin layer over the affected area twice daily (morning and night) for 2 weeks (jock itch) or 4 weeks (athlete's foot & ringworm) - Supervise children in the use of this productFor athlete's foot  *pay special attention to the space between the toes  *wear well fitting, ventilated shoes  *change shoes and socks at least once dailyIf condition persists longer, or if irritiation occurs, consult a doctor. This formulation utilizes a cream delivery system. Marketed by Trividia Manufacturing Solutions, Inc, this product is identified by NDC 0159-2500 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
0159-2500-04
Package Description
117 g in 1 TUBE
Product Code
0159-2500
11-Digit Billing Format
00159250004

Clinical Specifications

Proprietary Name
Selan Antifungal
Non-Proprietary Name
Selan Antifungal
Substance Name
Miconazole Nitrate
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
MICONAZOLE NITRATE 2 g/100g
Pharmacologic Class
Usage Information
 - Clean affected area and dry thoroughly - Apply a thin layer over the affected area twice daily (morning and night) for 2 weeks (jock itch) or 4 weeks (athlete's foot & ringworm) - Supervise children in the use of this productFor athlete's foot  *pay special attention to the space between the toes  *wear well fitting, ventilated shoes  *change shoes and socks at least once dailyIf condition persists longer, or if irritiation occurs, consult a doctor. This product is not effective on the scalp or nails.

Regulatory & Marketing

Labeler Name
Trividia Manufacturing Solutions, Inc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-05-2003
End Marketing Date
12-30-2029
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 0159-2500-04 identifies a specific commercial package of 117 g in 1 tube of Selan Antifungal, a human over the counter drug labeled by Trividia Manufacturing Solutions, Inc. This cream is formulated for topical use and contains miconazole nitrate 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 Trividia Manufacturing Solutions, Inc on November 05, 2003.

How is this Trividia Manufacturing Solutions, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00159250004. 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 (4-4-2)
0159-2500-04
11-Digit CMS (5-4-2)
00159-2500-04

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