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  5. NDC Package Code: 55505-192-57 Nizoral

NDC Package 55505-192-57 Nizoral

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
55505-192-57
Package Description:
2 CARTON in 1 CARTON / 1 BOTTLE in 1 CARTON / 200 mL in 1 BOTTLE
Product Code:
55505-192
Proprietary Name:
Nizoral
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:
55505019257
NDC to RxNorm Crosswalk:
  • RxCUI: 240812 - ketoconazole 1 % Medicated Shampoo
  • RxCUI: 240812 - ketoconazole 10 MG/ML Medicated Shampoo
  • RxCUI: 608844 - Nizoral A-D 1 % Medicated Shampoo
  • RxCUI: 608844 - ketoconazole 10 MG/ML Medicated Shampoo [Nizoral]
  • RxCUI: 608844 - Nizoral 1 % Medicated Shampoo
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Kramer Laboratories
    Dosage Form:
    Shampoo - A liquid soap or detergent 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 10 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:
    NDA020310
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    01-07-2019
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    55505-192-331 BOTTLE in 1 CARTON / 125 mL in 1 BOTTLE
    55505-192-401 BOTTLE in 1 CARTON / 200 mL in 1 BOTTLE
    55505-192-592 CARTON in 1 CARTON / 325 mL in 1 CARTON

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 55505-192-57?

    The NDC Packaged Code 55505-192-57 is assigned to a package of 2 carton in 1 carton / 1 bottle in 1 carton / 200 ml in 1 bottle of Nizoral, a human over the counter drug labeled by Kramer Laboratories. The product's dosage form is shampoo and is administered via topical form.

    Is NDC 55505-192 included in the NDC Directory?

    Yes, Nizoral with product code 55505-192 is active and included in the NDC Directory. The product was first marketed by Kramer Laboratories on January 07, 2019 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 11-digit format for NDC 55505-192-57?

    The 11-digit format is 55505019257. 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 5-3-2 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
    5-3-255505-192-575-4-255505-0192-57