Clotrimazole Solution
NDC Package 69848-001-01

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

Package Information

Clotrimazole solution is clotrimazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). This formulation utilizes a solution delivery system. Marketed by Granules Usa, Inc., this product is identified by NDC 69848-001 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
69848-001-01
Package Description
10 mL in 1 BOTTLE
Product Code
69848-001
11-Digit Billing Format
69848000101

Clinical Specifications

Proprietary Name
Clotrimazole
Non-Proprietary Name
Clotrimazole
Substance Name
Clotrimazole
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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)
CLOTRIMAZOLE 1 g/mL
Pharmacologic Class
Usage Information
Clotrimazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Clotrimazole is an azole antifungal that works by preventing the growth of fungus.

Regulatory & Marketing

Labeler Name
Granules Usa, Inc.
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2018
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 69848-001-01 identifies a specific commercial package of 10 ml in 1 bottle of Clotrimazole, a human over the counter drug labeled by Granules Usa, Inc.. This solution is formulated for topical use and contains 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 Granules Usa, Inc. on July 01, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Clotrimazole is used to treat skin infections such as athlete's foot, jock itch, ringworm, and other fungal skin infections (candidiasis). This medication is also used to treat a skin condition known as pityriasis (tinea versicolor), a fungal infection that causes a lightening or darkening of the skin of the neck, chest, arms, or legs. Clotrimazole is an azole antifungal that works by preventing the growth of fungus.

How is this Granules Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69848000101. 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)
69848-001-01
11-Digit CMS (5-4-2)
69848-0001-01

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