NDC Package 50458-290-01 Sporanox

Itraconazole Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

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:
50458-290-01
Package Description:
3 BLISTER PACK in 1 CARTON / 10 CAPSULE in 1 BLISTER PACK
Product Code:
Proprietary Name:
Sporanox
Non-Proprietary Name:
Itraconazole
Substance Name:
Itraconazole
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:
50458029001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
3 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 311204 - itraconazole 100 MG Oral Capsule
  • RxCUI: 311204 - ICNZ 100 MG Oral Capsule
  • RxCUI: 833164 - Sporanox 100 MG Oral Capsule
  • RxCUI: 833164 - itraconazole 100 MG Oral Capsule [Sporanox]
  • RxCUI: 833164 - ICNZ 100 MG Oral Capsule [Sporanox]
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Janssen Pharmaceuticals, Inc.
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA020083
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    09-11-1992
    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
    50458-290-0430 CAPSULE in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50458-290-01?

    The NDC Packaged Code 50458-290-01 is assigned to a package of 3 blister pack in 1 carton / 10 capsule in 1 blister pack of Sporanox, a human prescription drug labeled by Janssen Pharmaceuticals, Inc.. The product's dosage form is capsule and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 3 billable units per package.

    Is NDC 50458-290 included in the NDC Directory?

    Yes, Sporanox with product code 50458-290 is active and included in the NDC Directory. The product was first marketed by Janssen Pharmaceuticals, Inc. on September 11, 1992 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 50458-290-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 3.

    What is the 11-digit format for NDC 50458-290-01?

    The 11-digit format is 50458029001. 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
    5-3-250458-290-015-4-250458-0290-01