Nystatin Suspension
NDC Package 64950-372-06

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 Genus Lifesciences Inc., this product is identified by NDC 64950-372 and is authorized under FDA application ANDA065148.

Identification & Billing

NDC Package Code
64950-372-06
Package Description
60 mL in 1 BOTTLE, DROPPER
Product Code
64950-372
11-Digit Billing Format
64950037206
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
Genus Lifesciences Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA065148
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-24-2026
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 (64950-372). Click a package code to view its specific billing and regulatory data.

64950-372-47
473 mL in 1 BOTTLE

* 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 64950-372-06 identifies a specific commercial package of 60 ml in 1 bottle, dropper of Nystatin, a human prescription drug labeled by Genus Lifesciences Inc.. 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 Genus Lifesciences Inc. on March 24, 2026. 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 Genus Lifesciences Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64950037206. 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)
64950-372-06
11-Digit CMS (5-4-2)
64950-0372-06

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