Nystatin Powder
NDC Package 65415-1371-2

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Nystatin powders is nystatin is used to treat fungal skin infections. This formulation utilizes a powder delivery system. Marketed by Antibiotice Sa, this product is identified by NDC 65415-1371.

Identification & Billing

NDC Package Code
65415-1371-2
Package Description
16 kg in 1 CARTON
Product Code
65415-1371
11-Digit Billing Format
65415137102

Clinical Specifications

Proprietary Name
Nystatin
Non-Proprietary Name
Nystatin
Substance Name
Nystatin
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
NYSTATIN 1 kg/kg
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
Antibiotice Sa
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
03-20-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 65415-1371-2 identifies a specific commercial package of 16 kg in 1 carton of Nystatin (UNFINISHED drug), a bulk ingredient labeled by Antibiotice Sa. This powder is formulated for 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 Antibiotice Sa on March 20, 2014. 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 Antibiotice Sa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65415137102. 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)
65415-1371-2
11-Digit CMS (5-4-2)
65415-1371-02

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