Clotrimazole Lozenge
NDC Package 16571-686-07

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 lozenges 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 lozenge delivery system. Marketed by Rising Pharma Holdings, Inc., this product is identified by NDC 16571-686 and is authorized under FDA application ANDA215641.

Identification & Billing

NDC Package Code
16571-686-07
Package Description
70 LOZENGE in 1 BOTTLE
Product Code
16571-686
11-Digit Billing Format
16571068607
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
70 EA
RxNorm Crosswalk
RxCUI: 309371 - clotrimazole 10 MG Oral Lozenge

Clinical Specifications

Proprietary Name
Clotrimazole
Non-Proprietary Name
Clotrimazole
Substance Name
Clotrimazole
Dosage Form
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
CLOTRIMAZOLE 10 mg/1
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
Rising Pharma Holdings, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA215641
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2024
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 (16571-686). Click a package code to view its specific billing and regulatory data.

16571-686-14
140 LOZENGE in 1 BOTTLE

* 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 16571-686-07 identifies a specific commercial package of 70 lozenge in 1 bottle of Clotrimazole, a human prescription drug labeled by Rising Pharma Holdings, Inc.. This lozenge is formulated for oral 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 Rising Pharma Holdings, Inc. on May 01, 2024. 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 Rising Pharma Holdings, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16571068607. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 70 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 (5-3-2)
16571-686-07
11-Digit CMS (5-4-2)
16571-0686-07

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