Posaconazole Tablet, Delayed Release
NDC Package 72319-023-02

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

Package Information

Posaconazole tablets 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 tablet, delayed release delivery system. Marketed by I3 Pharmaceuticals, Llc, this product is identified by NDC 72319-023 and is authorized under FDA application ANDA216488.

Identification & Billing

NDC Package Code
72319-023-02
Package Description
60 TABLET, DELAYED RELEASE in 1 BOTTLE
Product Code
72319-023
11-Digit Billing Format
72319002302
RxNorm Crosswalk
RxCUI: 1482908 - posaconazole 100 MG Delayed Release Oral Tablet

Clinical Specifications

Proprietary Name
Posaconazole
Non-Proprietary Name
Posaconazole
Substance Name
Posaconazole
Dosage Form
Tablet, Delayed Release - A solid dosage form which releases a drug (or drugs) at a time other than promptly after administration. Enteric-coated articles are delayed release dosage forms.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
POSACONAZOLE 100 mg/1
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
I3 Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA216488
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-15-2023
Listing Expiration
12-31-2026
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 72319-023-02 identifies a specific commercial package of 60 tablet, delayed release in 1 bottle of Posaconazole, a human prescription drug labeled by I3 Pharmaceuticals, Llc. This tablet, delayed release 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 I3 Pharmaceuticals, Llc on September 15, 2023. The current certification is valid through December 31, 2026.

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 I3 Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72319002302. 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)
72319-023-02
11-Digit CMS (5-4-2)
72319-0023-02

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