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  5. NDC Package Code: 72189-428-07 Ketoconazole

NDC Package 72189-428-07 Ketoconazole

Tablet Oral - 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:
72189-428-07
Package Description:
7 TABLET in 1 BOTTLE
Product Code:
72189-428
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:
72189042807
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
7 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 197853 - ketoconazole 200 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Direct_rx
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • KETOCONAZOLE 200 mg/1
    • 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:
    ANDA075319
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-01-2023
    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 72189-428-07?

    The NDC Packaged Code 72189-428-07 is assigned to a package of 7 tablet in 1 bottle of Ketoconazole, a human prescription drug labeled by Direct_rx. The product's dosage form is tablet and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 7 billable units per package.

    Is NDC 72189-428 included in the NDC Directory?

    Yes, Ketoconazole with product code 72189-428 is active and included in the NDC Directory. The product was first marketed by Direct_rx on March 01, 2023 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 72189-428-07?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 7.

    What is the 11-digit format for NDC 72189-428-07?

    The 11-digit format is 72189042807. 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
    5-3-272189-428-075-4-272189-0428-07