Clotrimazole And Betamethasone Dipropionate Cream
NDC Package 63187-095-45

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

Clotrimazole And Betamethasone Dipropionate cream is 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. This formulation utilizes a cream delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 63187-095 and is authorized under FDA application ANDA076002.

Identification & Billing

NDC Package Code
63187-095-45
Package Description
1 TUBE in 1 CARTON / 45 g in 1 TUBE
Product Code
63187-095
11-Digit Billing Format
63187009545
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
Non-Proprietary Name
Clotrimazole And Betamethasone Dipropionate
Substance Name
Betamethasone Dipropionate; Clotrimazole
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)
Pharmacologic Class
Usage Information
Clotrimazole and Betamethasone Dipropionate Cream is 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 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 in the treatment of infections caused by Microsporum canis have been reported

Regulatory & Marketing

Labeler Name
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
ANDA076002
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-03-2007
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (63187-095). Click a package code to view its specific billing and regulatory data.

63187-095-15
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 63187-095-45 identifies a specific commercial package of 1 tube in 1 carton / 45 g in 1 tube of Clotrimazole And Betamethasone Dipropionate, a human prescription drug labeled by Proficient Rx Lp. This cream is formulated for topical use and contains betamethasone dipropionate; clotrimazole 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 Proficient Rx Lp on January 03, 2007. The current certification is valid through December 31, 2026.

How is this Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63187009545. 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)
63187-095-45
11-Digit CMS (5-4-2)
63187-0095-45

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