Nystatin Suspension
NDC Package 81033-015-01

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 Kesin Pharma Corporation, this product is identified by NDC 81033-015 and is authorized under FDA application ANDA062832.

Identification & Billing

NDC Package Code
81033-015-01
Package Description
100 CUP, UNIT-DOSE in 1 CASE / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05)
Product Code
81033-015
11-Digit Billing Format
81033001501
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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.
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
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
Kesin Pharma Corporation
Product Type
Human Prescription Drug
FDA Application #
ANDA062832
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-14-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (81033-015). Click a package code to view its specific billing and regulatory data.

81033-015-54
50 CUP, UNIT-DOSE in 1 CARTON / 5 mL in 1 CUP, UNIT-DOSE (81033-015-05)

* 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 81033-015-01 identifies a specific commercial package of 100 cup, unit-dose in 1 case / 5 ml in 1 cup, unit-dose (81033-015-05) of Nystatin, a human prescription drug labeled by Kesin Pharma Corporation. 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 Kesin Pharma Corporation on August 14, 2020. 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 Kesin Pharma Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81033001501. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
81033-015-01
11-Digit CMS (5-4-2)
81033-0015-01

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