Voriconazole Powder, For Suspension
NDC Package 43386-038-60

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

Package Information

Voriconazole powders is voriconazole is used to treat a variety of fungal infections. This formulation utilizes a powder, for suspension delivery system. Marketed by Lupin Pharmaceuticals,inc., this product is identified by NDC 43386-038 and is authorized under FDA application ANDA206799.

Identification & Billing

NDC Package Code
43386-038-60
Package Description
1 BOTTLE in 1 CARTON / 75 mL in 1 BOTTLE
Product Code
43386-038
11-Digit Billing Format
43386003860
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Voriconazole
Non-Proprietary Name
Voriconazole
Substance Name
Voriconazole
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
VORICONAZOLE 40 mg/mL
Pharmacologic Class
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
Lupin Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA206799
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2016
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 43386-038-60 identifies a specific commercial package of 1 bottle in 1 carton / 75 ml in 1 bottle of Voriconazole, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. This powder, for suspension is formulated for oral use and contains voriconazole as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Lupin Pharmaceuticals,inc. on June 01, 2016. The current certification is valid through December 31, 2026.

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 Lupin Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43386003860. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
43386-038-60
11-Digit CMS (5-4-2)
43386-0038-60

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