1. Home
  2. Labeler Index
  3. Amneal Pharmaceuticals Llc
  4. 65162-087
  5. NDC Package Code: 65162-087-74 Itraconazole

NDC Package 65162-087-74 Itraconazole

Solution Oral - 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:
65162-087-74
Package Description:
150 mL in 1 BOTTLE, GLASS
Product Code:
65162-087
Proprietary Name:
Itraconazole
Non-Proprietary Name:
Itraconazole
Substance Name:
Itraconazole
Usage Information:
Itraconazole is used to treat a variety of fungal infections. It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi.
11-Digit NDC Billing Format:
65162008774
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
150 ML
Product Type:
Human Prescription Drug
Labeler Name:
Amneal Pharmaceuticals Llc
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ITRACONAZOLE 10 mg/mL
    • Pharmacologic Class(es):
  • Azole Antifungal - [EPC] (Established Pharmacologic Class)
  • Azoles - [CS]
  • Breast Cancer Resistance Protein Inhibitors - [MoA] (Mechanism of Action)
  • Cytochrome P450 3A4 Inhibitors - [MoA] (Mechanism of Action)
  • P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA205573
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-30-2014
    Listing Expiration Date:
    12-31-2025
    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
    65162-087-3410 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 65162-087-74?

    The NDC Packaged Code 65162-087-74 is assigned to a package of 150 ml in 1 bottle, glass of Itraconazole, a human prescription drug labeled by Amneal Pharmaceuticals Llc. The product's dosage form is solution and is administered via oral form.

    Is NDC 65162-087 included in the NDC Directory?

    Yes, Itraconazole with product code 65162-087 is active and included in the NDC Directory. The product was first marketed by Amneal Pharmaceuticals Llc on April 30, 2014 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 65162-087-74?

    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 150.

    What is the 11-digit format for NDC 65162-087-74?

    The 11-digit format is 65162008774. 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
    5-3-265162-087-745-4-265162-0087-74