Nystatin
NDC Package 21695-643-60

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Nystatin is used to treat fungal skin infections. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-643 and is authorized under FDA application ANDA065148.

Identification & Billing

NDC Package Code
21695-643-60
Package Description
60 mL in 1 BOTTLE, DROPPER
Product Code
21695-643
11-Digit Billing Format
21695064360
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
60 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nystatin
Dosage Form
-
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
Rebel Distributors Corp
FDA Application #
ANDA065148
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-28-2005
Listing Expiration
12-31-2017
Exclude Flag
I
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 21695-643-60 identifies a specific commercial package of 60 ml in 1 bottle, dropper of Nystatin, labeled by Rebel Distributors Corp. This product is billed per "ML" milliliter and contains an estimated amount of 60 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rebel Distributors Corp on June 28, 2005. The current certification is valid through December 31, 2017.

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 Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695064360. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 60 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)
21695-643-60
11-Digit CMS (5-4-2)
21695-0643-60

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