Itraconazole
NDC Package 42543-113-33

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Itraconazole is used to treat a variety of fungal infections. Marketed by Vensun Pharmaceuticals, Inc., this product is identified by NDC 42543-113 and is authorized under FDA application ANDA206410.

Identification & Billing

NDC Package Code
42543-113-33
Package Description
3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
Product Code
42543-113
11-Digit Billing Format
42543011333

Clinical Specifications

Proprietary Name
Itraconazole
Dosage Form
-
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
Vensun Pharmaceuticals, Inc.
FDA Application #
ANDA206410
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-31-2020
End Marketing Date
02-01-2020
Listing Expiration
02-01-2020
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (42543-113). Click a package code to view its specific billing and regulatory data.

42543-113-01
100 CAPSULE in 1 BOTTLE, PLASTIC
42543-113-30
30 CAPSULE in 1 BOTTLE, PLASTIC

* 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 42543-113-33 identifies a specific commercial package of 3 blister pack in 1 carton / 10 capsule in 1 blister pack of Itraconazole, labeled by Vensun Pharmaceuticals, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Vensun Pharmaceuticals, Inc. on January 31, 2020. The current certification is valid through February 01, 2020.

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 Vensun Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42543011333. 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)
42543-113-33
11-Digit CMS (5-4-2)
42543-0113-33

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