Clotrimazole And Betamethasone Dipropionate
NDC Package 50436-4546-1

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 And Betamethasone Dipropionate is cream, 1%/0.05% (base) is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. Marketed by Unit Dose Services, this product is identified by NDC 50436-4546 and is authorized under FDA application ANDA075502.

Identification & Billing

NDC Package Code
50436-4546-1
Package Description
15 g in 1 TUBE
Product Code
50436-4546
11-Digit Billing Format
50436454601
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
15 GM
RxNorm Crosswalk
  • RxCUI: 308714 - clotrimazole 1 % / betamethasone 0.05 % Topical Cream
  • RxCUI: 308714 - betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream
  • RxCUI: 308714 - betamethasone 0.05 % / clotrimazole 1 % Topical Cream
  • RxCUI: 308714 - betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Clotrimazole And Betamethasone Dipropionate
Dosage Form
-
Usage Information
Clotrimazole and Betamethasone Dipropionate Cream, 1%/0.05% (base) is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older.

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
ANDA075502
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-05-2001
Listing Expiration
12-31-2020
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 50436-4546-1 identifies a specific commercial package of 15 g in 1 tube of Clotrimazole And Betamethasone Dipropionate, labeled by Unit Dose Services. This product is billed per "GM" gram and contains an estimated amount of 15 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 Unit Dose Services on June 05, 2001. The current certification is valid through December 31, 2020.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436454601. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 15 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 (5-4-1)
50436-4546-1
11-Digit CMS (5-4-2)
50436-4546-01

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