Nystatin
NDC Package 68258-3046-3

11-digit billing NDC: 68258304603
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 cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.This cream is not indicated for systemic, oral, intravaginal or ophthalmic use. Marketed by Dispensing Solutions, Inc., this product is identified by NDC 68258-3046 and is authorized under FDA application ANDA065315.

Identification & Billing

NDC Package Code
68258-3046-3
Package Description
30 g in 1 TUBE
Product Code
68258-3046
11-Digit Billing Format
68258304603
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Nystatin
Dosage Form
-
Usage Information
Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

Regulatory & Marketing

Labeler Name
Dispensing Solutions, Inc.
FDA Application #
ANDA065315
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-31-2006
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 68258-3046-3 identifies a specific commercial package of 30 g in 1 tube of Nystatin, labeled by Dispensing Solutions, Inc.. 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 Dispensing Solutions, Inc. on May 31, 2006. The current certification is valid through December 31, 2017.

How is this Dispensing Solutions, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68258304603. 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)
68258-3046-3
11-Digit CMS (5-4-2)
68258-3046-03

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