Nystatin Topical Powder
NDC Package 42806-178-30

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 Topical Powder powders is nystatin is used to treat fungal skin infections. This formulation utilizes a powder delivery system. Marketed by Epic Pharma, Llc, this product is identified by NDC 42806-178 and is authorized under FDA application ANDA210532.

Identification & Billing

NDC Package Code
42806-178-30
Package Description
30 g in 1 BOTTLE
Product Code
42806-178
11-Digit Billing Format
42806017830
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
30 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nystatin Topical Powder
Non-Proprietary Name
Nystatin Topical Powder
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.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
NYSTATIN 100000 U/g
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
Epic Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA210532
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-02-2018
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 (42806-178). Click a package code to view its specific billing and regulatory data.

42806-178-15
15 g in 1 BOTTLE
42806-178-60
60 g 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 42806-178-30 identifies a specific commercial package of 30 g in 1 bottle of Nystatin Topical Powder, a human prescription drug labeled by Epic Pharma, Llc. This powder is formulated for topical 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 Epic Pharma, Llc on May 02, 2018. 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 Epic Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42806017830. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 30 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)
42806-178-30
11-Digit CMS (5-4-2)
42806-0178-30

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