Noxafil Solution
NDC Package 0085-4331-01

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

Package Information

Noxafil (posaconazole) solution is posaconazole is used to prevent certain fungal infections in patients who have severely weakened immune systems (such as patients who have had chemotherapy). This formulation utilizes a solution delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0085-4331 and is authorized under FDA application NDA205596.

Identification & Billing

NDC Package Code
0085-4331-01
Package Description
1 VIAL, GLASS in 1 CARTON / 16.7 mL in 1 VIAL, GLASS
Product Code
0085-4331
11-Digit Billing Format
00085433101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Noxafil
Non-Proprietary Name
Posaconazole
Substance Name
Posaconazole
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
POSACONAZOLE 18 mg/mL
Pharmacologic Class
Usage Information
Posaconazole is used to prevent certain fungal infections in patients who have severely weakened immune systems (such as patients who have had chemotherapy). It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi.

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Human Prescription Drug
FDA Application #
NDA205596
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-13-2014
Listing Expiration
12-31-2027
Exclude Flag
N
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 0085-4331-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 16.7 ml in 1 vial, glass of Noxafil, a human prescription drug labeled by Merck Sharp & Dohme Llc. This solution is formulated for intravenous use and contains posaconazole 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 Merck Sharp & Dohme Llc on March 13, 2014. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Posaconazole is used to prevent certain fungal infections in patients who have severely weakened immune systems (such as patients who have had chemotherapy). It belongs to a class of drugs known as azole antifungals. It works by stopping the growth of fungi.

How is this Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00085433101. 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 (4-4-2)
0085-4331-01
11-Digit CMS (5-4-2)
00085-4331-01

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