Voriconazole
NDC Package 0378-6270-45

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.

Voriconazole is used to treat a variety of fungal infections. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-6270 and is authorized under FDA application ANDA202361.

Identification & Billing

NDC Package Code
0378-6270-45
Package Description
75 mL in 1 BOTTLE, PLASTIC
Product Code
0378-6270
11-Digit Billing Format
00378627045
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
75 ML

Clinical Specifications

Proprietary Name
Voriconazole
Dosage Form
-
Usage Information
Voriconazole 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
Mylan Pharmaceuticals Inc.
FDA Application #
ANDA202361
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-25-2013
End Marketing Date
10-31-2018
Listing Expiration
10-31-2018
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 0378-6270-45 identifies a specific commercial package of 75 ml in 1 bottle, plastic of Voriconazole, labeled by Mylan Pharmaceuticals Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 75 billable units per package. 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 Mylan Pharmaceuticals Inc. on September 25, 2013. The current certification is valid through October 31, 2018.

What are the primary indications for this medication?

Voriconazole 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 Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378627045. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 75 total billable units per package. 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)
0378-6270-45
11-Digit CMS (5-4-2)
00378-6270-45

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