Ketoconazole
NDC Package 68788-9708-3

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

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ketoconazole is a medication used to control dandruff. Marketed by Preferred Pharmaceuticals, Inc., this product is identified by NDC 68788-9708 and is authorized under FDA application ANDA075319.

Identification & Billing

NDC Package Code
68788-9708-3
Package Description
30 TABLET in 1 BOTTLE
Product Code
68788-9708
11-Digit Billing Format
68788970803

Clinical Specifications

Proprietary Name
Ketoconazole
Dosage Form
-
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
Preferred Pharmaceuticals, Inc.
FDA Application #
ANDA075319
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-05-2013
End Marketing Date
06-09-2021
Listing Expiration
06-09-2021
Exclude Flag
D
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 (68788-9708). Click a package code to view its specific billing and regulatory data.

68788-9708-1
10 TABLET in 1 BOTTLE
68788-9708-6
60 TABLET 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 68788-9708-3 identifies a specific commercial package of 30 tablet in 1 bottle of Ketoconazole, labeled by Preferred Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Preferred Pharmaceuticals, Inc. on February 05, 2013. The current certification is valid through June 09, 2021.

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 Preferred Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68788970803. 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)
68788-9708-3
11-Digit CMS (5-4-2)
68788-9708-03

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