Ketoconazole Shampoo, Suspension
NDC Package 68071-5294-4

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

Package Information

Ketoconazole shampoos is a medication used to control dandruff. This formulation utilizes a shampoo, suspension delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-5294 and is authorized under FDA application ANDA076419.

Identification & Billing

NDC Package Code
68071-5294-4
Package Description
120 mL in 1 BOTTLE
Product Code
68071-5294
11-Digit Billing Format
68071529404
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ketoconazole
Non-Proprietary Name
Ketoconazole
Substance Name
Ketoconazole
Dosage Form
Shampoo, Suspension - A liquid soap or detergent containing one or more solid, insoluble substances dispersed in a liquid vehicle that is used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.
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 20 mg/mL
Pharmacologic Class
Usage Information
This medication is used to control dandruff. Use of this medication may help to relieve the flaking, scaling and itching associated with dandruff. Ketoconazole is an azole antifungal that works by preventing the growth of fungus. Ketoconazole 2% shampoo 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.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA076419
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-01-2025
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 68071-5294-4 identifies a specific commercial package of 120 ml in 1 bottle of Ketoconazole, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This shampoo, suspension 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 Nucare Pharmaceuticals, Inc. on December 01, 2025. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to control dandruff. Use of this medication may help to relieve the flaking, scaling and itching associated with dandruff. Ketoconazole is an azole antifungal that works by preventing the growth of fungus. Ketoconazole 2% shampoo 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.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071529404. 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)
68071-5294-4
11-Digit CMS (5-4-2)
68071-5294-04

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