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  5. NDC Package Code: 68788-8257-1 Ketoconazole

NDC Package 68788-8257-1 Ketoconazole

Shampoo, Suspension Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
68788-8257-1
Package Description:
120 mL in 1 BOTTLE, PLASTIC
Product Code:
68788-8257
Proprietary Name:
Ketoconazole
Non-Proprietary Name:
Ketoconazole
Substance Name:
Ketoconazole
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.
11-Digit NDC Billing Format:
68788825701
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
120 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 106336 - ketoconazole 2 % Medicated Shampoo
  • RxCUI: 106336 - ketoconazole 20 MG/ML Medicated Shampoo
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Preferred Pharmaceuticals Inc.
    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(s):
  • 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(es):
  • Azole Antifungal - [EPC] (Established Pharmacologic Class)
  • Azoles - [CS]
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A5 Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA076942
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-16-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 68788-8257-1?

    The NDC Packaged Code 68788-8257-1 is assigned to a package of 120 ml in 1 bottle, plastic of Ketoconazole, a human prescription drug labeled by Preferred Pharmaceuticals Inc.. The product's dosage form is shampoo, suspension and is administered via topical form.This product is billed per "ML" milliliter and contains an estimated amount of 120 billable units per package.

    Is NDC 68788-8257 included in the NDC Directory?

    Yes, Ketoconazole with product code 68788-8257 is active and included in the NDC Directory. The product was first marketed by Preferred Pharmaceuticals Inc. on September 16, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 68788-8257-1?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 120.

    What is the 11-digit format for NDC 68788-8257-1?

    The 11-digit format is 68788825701. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-168788-8257-15-4-268788-8257-01