Nystatin Suspension
NDC Package 17856-0508-3

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

Nystatin suspension is nystatin is used to treat fungal skin infections. This formulation utilizes a suspension delivery system. Marketed by Atlantic Biologicals Corp., this product is identified by NDC 17856-0508 and is authorized under FDA application ANDA214346.

Identification & Billing

NDC Package Code
17856-0508-3
Package Description
48 SYRINGE in 1 BOX, UNIT-DOSE / 5 mL in 1 SYRINGE
Product Code
17856-0508
11-Digit Billing Format
17856050803
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nystatin
Non-Proprietary Name
Nystatin
Substance Name
Nystatin
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)
NYSTATIN 100000 [USP'U]/mL
Pharmacologic Class
Usage Information
Nystatin is used to treat fungal skin infections. Nystatin is an antifungal that works by stopping the growth of fungus.

Regulatory & Marketing

Labeler Name
Atlantic Biologicals Corp.
Product Type
Human Prescription Drug
FDA Application #
ANDA214346
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-05-2022
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 (17856-0508). Click a package code to view its specific billing and regulatory data.

17856-0508-1
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 5 mL in 1 CUP, UNIT-DOSE
17856-0508-5
48 SYRINGE in 1 BOX, UNIT-DOSE / 5 mL in 1 SYRINGE
17856-0508-7
120 SYRINGE in 1 BOX, UNIT-DOSE / 1 mL in 1 SYRINGE

* 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 17856-0508-3 identifies a specific commercial package of 48 syringe in 1 box, unit-dose / 5 ml in 1 syringe of Nystatin, a human prescription drug labeled by Atlantic Biologicals Corp.. This suspension is formulated for oral use and contains nystatin 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 December 05, 2022. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Nystatin is used to treat fungal skin infections. Nystatin is an antifungal that works by stopping the growth of fungus.

How is this Atlantic Biologicals Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17856050803. 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)
17856-0508-3
11-Digit CMS (5-4-2)
17856-0508-03

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