Posaconazole Granule
NDC Package 12860-0133-0

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Posaconazole granules 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 granule delivery system. Marketed by N.v. Organon, this product is identified by NDC 12860-0133.

Identification & Billing

NDC Package Code
12860-0133-0
Package Description
33333 GRANULE in 1 DRUM
Product Code
12860-0133
11-Digit Billing Format
12860013300

Clinical Specifications

Proprietary Name
Posaconazole
Non-Proprietary Name
Posaconazole
Substance Name
Posaconazole
Dosage Form
Granule - A small particle or grain.
Active Ingredient(s)
POSACONAZOLE 300 mg/1
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
N.v. Organon
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
06-08-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 12860-0133-0 identifies a specific commercial package of 33333 granule in 1 drum of Posaconazole (UNFINISHED drug), drug for further processing labeled by N.v. Organon. This granule is formulated for 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 N.v. Organon on June 08, 2021. 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 N.v. Organon product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 12860013300. 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 (5-4-1)
12860-0133-0
11-Digit CMS (5-4-2)
12860-0133-00

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