Posaconazole Suspension
NDC Package 0254-1016-36

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

Package Information

Posaconazole suspension 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 suspension delivery system. Marketed by Endo Usa, Inc., this product is identified by NDC 0254-1016 and is authorized under FDA application NDA022003.

Identification & Billing

NDC Package Code
0254-1016-36
Package Description
1 BOTTLE, GLASS in 1 CARTON / 105 mL in 1 BOTTLE, GLASS
Product Code
0254-1016
11-Digit Billing Format
00254101636
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Posaconazole
Non-Proprietary Name
Posaconazole
Substance Name
Posaconazole
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
POSACONAZOLE 40 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
Endo Usa, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022003
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
03-29-2023
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 0254-1016-36 identifies a specific commercial package of 1 bottle, glass in 1 carton / 105 ml in 1 bottle, glass of Posaconazole, a human prescription drug labeled by Endo Usa, Inc.. This suspension is formulated for oral 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 Endo Usa, Inc. on March 29, 2023. 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 Endo Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00254101636. 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)
0254-1016-36
11-Digit CMS (5-4-2)
00254-1016-36

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