Clotrimazole
NDC Package 21695-935-45

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.

Clotrimazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). Marketed by Rebel Distributors Corp., this product is identified by NDC 21695-935 and is authorized under FDA application ANDA074165.

Identification & Billing

NDC Package Code
21695-935-45
Package Description
45 g in 1 TUBE
Product Code
21695-935
11-Digit Billing Format
21695093545
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 GM

Clinical Specifications

Proprietary Name
Clotrimazole
Dosage Form
-
Usage Information
Clotrimazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Clotrimazole is an azole antifungal that works by preventing the growth of fungus.

Regulatory & Marketing

Labeler Name
Rebel Distributors Corp.
FDA Application #
ANDA074165
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-16-1993
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 21695-935-45 identifies a specific commercial package of 45 g in 1 tube of Clotrimazole, labeled by Rebel Distributors Corp.. This product is billed per "GM" gram and contains an estimated amount of 45 billable units per package. 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 Rebel Distributors Corp. on July 16, 1993. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

Clotrimazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Clotrimazole is an azole antifungal that works by preventing the growth of fungus.

How is this Rebel Distributors Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695093545. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 45 total billable units per package. 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)
21695-935-45
11-Digit CMS (5-4-2)
21695-0935-45

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