Clotrimazole And Betamethasone Dipropionate
NDC Package 54868-4546-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4546 and is authorized under FDA application ANDA075673.

Identification & Billing

NDC Package Code
54868-4546-0
Package Description
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code
54868-4546
11-Digit Billing Format
54868454600
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
45 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
  • RxCUI: 308715 - clotrimazole 1 % / betamethasone dipropionate 0.05 % Topical Lotion

Clinical Specifications

Proprietary Name
Clotrimazole And Betamethasone Dipropionate
Dosage Form
-
Usage Information
Clotrimazole and Betamethasone Dipropionate Cream and Lotion are indicated in patients 17 years and older for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes and Trichophyton rubrum. Effective treatment without the risks associated with topical corticosteroid use may be obtained using a topical antifungal agent that does not contain a corticosteroid, especially for noninflammatory tinea infections. The efficacy of Clotrimazole and Betamethasone Dipropionate Cream or Lotion for the treatment of infections caused by zoophilic dermatophytes (e.g. Microsporum canis) has not been established. Several cases of treatment failure of Clotrimazole and Betamethasone Dipropionate Cream, USP in the treatment of infections caused by Microsporum canis have been reported.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA075673
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-31-2001
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (54868-4546). Click a package code to view its specific billing and regulatory data.

54868-4546-1
1 TUBE in 1 CARTON / 15 g in 1 TUBE

* 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 54868-4546-0 identifies a specific commercial package of 1 tube in 1 carton / 45 g in 1 tube of Clotrimazole And Betamethasone Dipropionate, labeled by Physicians Total Care, Inc.. 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 Physicians Total Care, Inc. on August 31, 2001. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868454600. 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 (5-4-1)
54868-4546-0
11-Digit CMS (5-4-2)
54868-4546-00

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