Itraconazole Oral Solution
NDC Package 69339-159-17

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Itraconazole Oral (itraconazole) solution is itraconazole is used to treat a variety of fungal infections. This formulation utilizes a solution delivery system. Marketed by Natco Pharma Usa Llc, this product is identified by NDC 69339-159 and is authorized under FDA application ANDA212239.

Identification & Billing

NDC Package Code
69339-159-17
Package Description
40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 10 mL in 1 CUP, UNIT-DOSE (69339-159-01)
Product Code
69339-159
11-Digit Billing Format
69339015917
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Itraconazole Oral
Non-Proprietary Name
Itraconazole
Substance Name
Itraconazole
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ITRACONAZOLE 10 mg/mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Natco Pharma Usa Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212239
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-25-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69339-159-17 identifies a specific commercial package of 40 cup, unit-dose in 1 box, unit-dose / 10 ml in 1 cup, unit-dose (69339-159-01) of Itraconazole Oral, a human prescription drug labeled by Natco Pharma Usa Llc. This solution is formulated for oral use and contains itraconazole as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Natco Pharma Usa Llc on April 25, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Natco Pharma Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69339015917. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
69339-159-17
11-Digit CMS (5-4-2)
69339-0159-17

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.