NDC Package 50458-295-15 Sporanox

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

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

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:

50458-295-15

Package Description:

150 mL in 1 BOTTLE

Product Code:

50458-295

Proprietary Name:

Sporanox

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.

11-Digit NDC Billing Format:

50458029515

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

150 ML

Labeler Name:

Janssen Pharmaceuticals, Inc.

Sample Package:

FDA Application Number:

NDA020657

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

02-21-1997

End Marketing Date:

05-31-2025

Listing Expiration Date:

05-31-2025

Exclude Flag:

Code Structure:

50458 - Janssen Pharmaceuticals, Inc.
- 50458-295 - Sporanox
  - 50458-295-15 - 150 mL in 1 BOTTLE

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 50458-295-15?

The NDC Packaged Code 50458-295-15 is assigned to a package of 150 ml in 1 bottle of Sporanox, labeled by Janssen Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

Is NDC 50458-295 included in the NDC Directory?

No, Sporanox with product code 50458-295 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Janssen Pharmaceuticals, Inc. on February 21, 1997 and its listing in the NDC Directory is set to expire on May 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 50458-295-15?

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 50458-295-15?

The 11-digit format is 50458029515. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	50458-295-15	5-4-2	50458-0295-15

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