Itraconazole
NDC Package 0185-0550-28

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 Eon Labs, Inc., this product is identified by NDC 0185-0550 and is authorized under FDA application ANDA076104.

Identification & Billing

NDC Package Code
0185-0550-28
Package Description
28 CAPSULE in 1 BOTTLE
Product Code
0185-0550
11-Digit Billing Format
00185055028

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
Eon Labs, Inc.
FDA Application #
ANDA076104
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-28-2004
End Marketing Date
04-30-2017
Listing Expiration
04-30-2017
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 (0185-0550). Click a package code to view its specific billing and regulatory data.

0185-0550-01
100 CAPSULE in 1 BOTTLE
0185-0550-05
500 CAPSULE in 1 BOTTLE
0185-0550-30
30 CAPSULE in 1 BOTTLE
0185-0550-83
7 CAPSULE in 1 CARTON
0185-0550-90
4 CAPSULE in 1 BLISTER PACK

* 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 0185-0550-28 identifies a specific commercial package of 28 capsule in 1 bottle of Itraconazole, labeled by Eon Labs, 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 Eon Labs, Inc. on May 28, 2004. The current certification is valid through April 30, 2017.

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 Eon Labs, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00185055028. 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 (4-4-2)
0185-0550-28
11-Digit CMS (5-4-2)
00185-0550-28

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