Tagrit Antifungal Treament Ketoconazole 1% Cream
NDC Package 85384-0002-1

11-digit billing NDC: 85384000201
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Tagrit Antifungal Treament Ketoconazole 1% (ketoconazole) cream is treats fungal infections of the skin, such as folliculitis, athlete's foot, jock itch, ringworm, and seborrheic dermatitis. This formulation utilizes a cream delivery system. Marketed by Tagrid Llc, this product is identified by NDC 85384-0002 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85384-0002-1
Package Description
100 g in 1 TUBE
Product Code
85384-0002
11-Digit Billing Format
85384000201

Clinical Specifications

Proprietary Name
Tagrit Antifungal Treament Ketoconazole 1%
Non-Proprietary Name
Ketoconazole
Substance Name
Ketoconazole
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)
KETOCONAZOLE 10 mg/1000g
Pharmacologic Class
Usage Information
Treats fungal infections of the skin, such as folliculitis, athlete's foot, jock itch, ringworm, and seborrheic dermatitis. Effective for relieving symptoms of itching, scaling, redness, and discomfort caused by fungal infections. Helps reduce and control fungal skin infections, including tinea corporis (body fungus), tinea cruris (groin fungus), tinea pedis (foot fungus), and tinea versicolor. Can be used on areas prone to fungal growth, such as the scalp,face,chest, back, arms, and legs.

Regulatory & Marketing

Labeler Name
Tagrid Llc
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-18-2025
Listing Expiration
12-31-2027
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 85384-0002-1 identifies a specific commercial package of 100 g in 1 tube of Tagrit Antifungal Treament Ketoconazole 1%, a human over the counter drug labeled by Tagrid Llc. This cream is formulated for topical use and contains ketoconazole 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 Tagrid Llc on April 18, 2025. The current certification is valid through December 31, 2027.

How is this Tagrid Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85384000201. 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)
85384-0002-1
11-Digit CMS (5-4-2)
85384-0002-01

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