Nystatin Cream
NDC Package 67296-2350-3

11-digit billing NDC: 67296235003
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nystatin (nystatin cream) cream is nystatin Cream, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicansand other susceptible Candidaspecies. This formulation utilizes a cream delivery system. Marketed by Redpharm Drug, this product is identified by NDC 67296-2350 and is authorized under FDA application ANDA061966.

Identification & Billing

NDC Package Code
67296-2350-3
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
67296-2350
11-Digit Billing Format
67296235003

Clinical Specifications

Proprietary Name
Nystatin
Non-Proprietary Name
Nystatin Cream
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 [USP'U]/g
Pharmacologic Class
Usage Information
Nystatin Cream, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicansand other susceptible Candidaspecies. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

Regulatory & Marketing

Labeler Name
Redpharm Drug
Product Type
Human Prescription Drug
FDA Application #
ANDA061966
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-01-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67296-2350-3 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Nystatin, a human prescription drug labeled by Redpharm Drug. 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 Redpharm Drug on April 01, 2015. The current certification is valid through December 31, 2027.

How is this Redpharm Drug product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67296235003. 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)
67296-2350-3
11-Digit CMS (5-4-2)
67296-2350-03

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