Clotrimazole And Betamethasone Dipropionate Cream
NDC Package 68071-4134-4

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Clotrimazole And Betamethasone Dipropionate cream is uSP 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. This formulation utilizes a cream delivery system. Marketed by Nucare Pharmaceuticals,inc., this product is identified by NDC 68071-4134 and is authorized under FDA application ANDA202894.

Identification & Billing

NDC Package Code
68071-4134-4
Package Description
45 g in 1 BOX
Product Code
68071-4134
11-Digit Billing Format
68071413404
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 USP 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
Nucare Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202894
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-06-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68071-4134-4 identifies a specific commercial package of 45 g in 1 box of Clotrimazole And Betamethasone Dipropionate, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. 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 Nucare Pharmaceuticals,inc. on November 06, 2015. The current certification is valid through December 31, 2026.

How is this Nucare Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071413404. 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)
68071-4134-4
11-Digit CMS (5-4-2)
68071-4134-04

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