Nystatin And Triamcinolone Acetonide
NDC Package 52565-042-15

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Nystatin And Triamcinolone Acetonide is ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment. Marketed by Teligent Pharma, Inc., this product is identified by NDC 52565-042 and is authorized under FDA application ANDA208287.

Identification & Billing

NDC Package Code
52565-042-15
Package Description
1 TUBE in 1 CARTON / 15 g in 1 TUBE
Product Code
52565-042
11-Digit Billing Format
52565004215
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
15 GM
RxNorm Crosswalk
  • RxCUI: 1053697 - nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Ointment
  • RxCUI: 1053697 - nystatin 100 UNT/MG / triamcinolone acetonide 0.001 MG/MG Topical Ointment
  • RxCUI: 1053697 - nystatin 100,000 UNT/GM / triamcinolone acetonide 0.1 % Topical Ointment

Clinical Specifications

Proprietary Name
Nystatin And Triamcinolone Acetonide
Dosage Form
-
Usage Information
Nystatin and Triamcinolone Acetonide Ointment is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.

Regulatory & Marketing

Labeler Name
Teligent Pharma, Inc.
FDA Application #
ANDA208287
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-30-2016
Listing Expiration
12-31-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52565-042). Click a package code to view its specific billing and regulatory data.

52565-042-30
1 TUBE in 1 CARTON / 30 g in 1 TUBE
52565-042-60
1 TUBE in 1 CARTON / 60 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 52565-042-15 identifies a specific commercial package of 1 tube in 1 carton / 15 g in 1 tube of Nystatin And Triamcinolone Acetonide, labeled by Teligent Pharma, 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 Teligent Pharma, Inc. on December 30, 2016. The current certification is valid through December 31, 2022.

How is this Teligent Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52565004215. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 15 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)
52565-042-15
11-Digit CMS (5-4-2)
52565-0042-15

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