Nystatin Cream
NDC Package 82804-045-30

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 cream is nystatin is used to treat fungal skin infections. This formulation utilizes a cream delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 82804-045 and is authorized under FDA application ANDA212557.

Identification & Billing

NDC Package Code
82804-045-30
Package Description
30 g in 1 TUBE
Product Code
82804-045
11-Digit Billing Format
82804004530
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
Non-Proprietary Name
Nystatin
Substance Name
Nystatin
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
ANDA212557
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-24-2019
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 (82804-045). Click a package code to view its specific billing and regulatory data.

82804-045-15
15 g in 1 TUBE

* 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 82804-045-30 identifies a specific commercial package of 30 g in 1 tube of Nystatin, a human prescription drug labeled by Proficient Rx Lp. This product is billed per "GM" gram and contains an estimated amount of 30 billable units per package. This cream 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 Proficient Rx Lp on July 24, 2019. 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 Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82804004530. 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)
82804-045-30
11-Digit CMS (5-4-2)
82804-0045-30

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