Clotrimazole And Betamethasone Dipropionate Lotion
NDC Package 51672-1308-3

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 lotions is clotrimazole and betamethasone dipropionate lotion 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 lotion delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 51672-1308 and is authorized under FDA application ANDA076493.

Identification & Billing

NDC Package Code
51672-1308-3
Package Description
1 BOTTLE in 1 CARTON / 30 mL in 1 BOTTLE
Product Code
51672-1308
11-Digit Billing Format
51672130803
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 308715 - clotrimazole 1 % / betamethasone dipropionate 0.05 % Topical Lotion
  • RxCUI: 308715 - betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Lotion
  • RxCUI: 308715 - betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) / clotrimazole 1 % Topical Lotion

Clinical Specifications

Proprietary Name
Clotrimazole And Betamethasone Dipropionate
Non-Proprietary Name
Clotrimazole And Betamethasone Dipropionate
Substance Name
Betamethasone Dipropionate; Clotrimazole
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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 lotion 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 lotion for the treatment of infections caused by zoophilic dermatophytes (e.g., Microsporum canis) has not been established.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076493
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-28-2004
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 51672-1308-3 identifies a specific commercial package of 1 bottle in 1 carton / 30 ml in 1 bottle of Clotrimazole And Betamethasone Dipropionate, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This lotion 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 Sun Pharmaceutical Industries, Inc. on July 28, 2004. The current certification is valid through December 31, 2026.

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51672130803. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
51672-1308-3
11-Digit CMS (5-4-2)
51672-1308-03

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