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  5. NDC Package Code: 43538-530-10 Ketodan

NDC Package 43538-530-10 Ketodan

Ketoconazole Aerosol, Foam 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:
43538-530-10
Package Description:
1 CAN in 1 CARTON / 100 g in 1 CAN
Product Code:
43538-530
Proprietary Name:
Ketodan
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:
43538053010
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
100 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 1300272 - Ketodan 2 % Topical Foam
  • RxCUI: 1300272 - ketoconazole 20 MG/ML Topical Foam [Ketodan]
  • RxCUI: 1300272 - Ketodan 20 MG/ML Topical Foam
  • RxCUI: 728550 - ketoconazole 2 % Topical Foam
  • RxCUI: 728550 - ketoconazole 20 MG/ML Topical Foam
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Medimetriks Pharmaceuticals, Inc.
    Dosage Form:
    Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
    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/g
    • 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:
    ANDA091550
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    06-15-2012
    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 43538-530-10?

    The NDC Packaged Code 43538-530-10 is assigned to a package of 1 can in 1 carton / 100 g in 1 can of Ketodan, a human prescription drug labeled by Medimetriks Pharmaceuticals, Inc.. The product's dosage form is aerosol, foam and is administered via topical form.

    Is NDC 43538-530 included in the NDC Directory?

    Yes, Ketodan with product code 43538-530 is active and included in the NDC Directory. The product was first marketed by Medimetriks Pharmaceuticals, Inc. on June 15, 2012 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 43538-530-10?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 43538-530-10?

    The 11-digit format is 43538053010. 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
    5-3-243538-530-105-4-243538-0530-10