Posaconazole Tablet, Delayed Release
NDC Package 17856-2133-5

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 Atlantic Biologicals Corp., this product is identified by NDC 17856-2133 and is authorized under FDA application ANDA212411.

Identification & Billing

NDC Package Code
17856-2133-5
Package Description
59 POUCH in 1 BOX / 1 TABLET, DELAYED RELEASE in 1 POUCH
Product Code
17856-2133
11-Digit Billing Format
17856213305
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
Atlantic Biologicals Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA212411
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-28-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (17856-2133). Click a package code to view its specific billing and regulatory data.

17856-2133-1
100 POUCH in 1 BOX, UNIT-DOSE / 1 TABLET, DELAYED RELEASE in 1 POUCH (17856-2133-2)

* 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 17856-2133-5 identifies a specific commercial package of 59 pouch in 1 box / 1 tablet, delayed release in 1 pouch of Posaconazole, a human prescription drug labeled by Atlantic Biologicals Corp.. 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 Atlantic Biologicals Corp. on August 28, 2019. 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 Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856213305. 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)
17856-2133-5
11-Digit CMS (5-4-2)
17856-2133-05

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