Sporanox
NDC Package 50458-298-01

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

Package Information

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

Sporanox is itraconazole solution is used to treat fungal infections in the mouth and throat. Marketed by Ortho-mcneil-janssen Pharmaceuticals, Inc., this product is identified by NDC 50458-298 and is authorized under FDA application NDA020301.

Identification & Billing

NDC Package Code
50458-298-01
Package Description
1 KIT in 1 CARTON * 50 mL in 1 BAG (0409-7984-65) * 25 mL in 1 AMPULE (50458-297-10)
Product Code
50458-298
11-Digit Billing Format
50458029801

Clinical Specifications

Proprietary Name
Sporanox
Dosage Form
-
Usage Information
Itraconazole solution is used to treat fungal infections in the mouth and throat. It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi.

Regulatory & Marketing

Labeler Name
Ortho-mcneil-janssen Pharmaceuticals, Inc.
FDA Application #
NDA020301
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-30-1999
End Marketing Date
12-31-2008
Listing Expiration
12-31-2008
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50458-298-01 identifies a specific commercial package of 1 kit in 1 carton * 50 ml in 1 bag (0409-7984-65) * 25 ml in 1 ampule (50458-297-10) of Sporanox, labeled by Ortho-mcneil-janssen 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 Ortho-mcneil-janssen Pharmaceuticals, Inc. on March 30, 1999. The current certification is valid through December 31, 2008.

What are the primary indications for this medication?

Itraconazole solution is used to treat fungal infections in the mouth and throat. It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi.

How is this Ortho-mcneil-janssen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50458029801. 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)
50458-298-01
11-Digit CMS (5-4-2)
50458-0298-01

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