Major Clotrimazole
NDC Package 76413-304-15

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.

Major Clotrimazole is clean the affected area and dry thoroughly.Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor.Supervise children in the use of this product.For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.For athlete's foot and ringworm, use daily for 4 weeks. Marketed by Central Texas Community Health Centers, this product is identified by NDC 76413-304 and is authorized under FDA application part333C.

Identification & Billing

NDC Package Code
76413-304-15
Package Description
1 TUBE in 1 CARTON / 14.17 g in 1 TUBE
Product Code
76413-304
11-Digit Billing Format
76413030415
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Major Clotrimazole
Dosage Form
-
Usage Information
Clean the affected area and dry thoroughly.Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor.Supervise children in the use of this product.For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.If conditions persists longer, consult a doctor.This product is not effective on the scalp or nails.

Regulatory & Marketing

Labeler Name
Central Texas Community Health Centers
FDA Application #
part333C
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
10-04-2004
Listing Expiration
12-31-2019
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 76413-304-15 identifies a specific commercial package of 1 tube in 1 carton / 14.17 g in 1 tube of Major Clotrimazole, labeled by Central Texas Community Health Centers. 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 Central Texas Community Health Centers on October 04, 2004. The current certification is valid through December 31, 2019.

How is this Central Texas Community Health Centers product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76413030415. 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)
76413-304-15
11-Digit CMS (5-4-2)
76413-0304-15

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