Nystatin Tablet, Coated
NDC Package 23155-051-01

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

Package Information

Nystatin tablets is nystatin is used to treat fungal skin infections. This formulation utilizes a tablet, coated delivery system. Marketed by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc., this product is identified by NDC 23155-051 and is authorized under FDA application ANDA062474.

Identification & Billing

NDC Package Code
23155-051-01
Package Description
100 TABLET, COATED in 1 BOTTLE
Product Code
23155-051
11-Digit Billing Format
23155005101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nystatin
Non-Proprietary Name
Nystatin
Substance Name
Nystatin
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NYSTATIN 500000 [USP'U]/1
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
Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA062474
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-31-2011
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 23155-051-01 identifies a specific commercial package of 100 tablet, coated in 1 bottle of Nystatin, a human prescription drug labeled by Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.. This tablet, coated 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 Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. on October 31, 2011. The current certification is valid through December 31, 2026.

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 Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 23155005101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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)
23155-051-01
11-Digit CMS (5-4-2)
23155-0051-01

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