Nystatin And Triamcinolone Acetonide Cream
NDC Package 68180-545-01

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 And Triamcinolone Acetonide cream is uSP 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. This formulation utilizes a cream delivery system. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 68180-545 and is authorized under FDA application ANDA208205.

Identification & Billing

NDC Package Code
68180-545-01
Package Description
1 TUBE in 1 CARTON / 15 g in 1 TUBE
Product Code
68180-545
11-Digit Billing Format
68180054501
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: 1053753 - nystatin 100,000 UNT/GM / triamcinolone acetonide 1 MG/GM Topical Cream
  • RxCUI: 1053753 - nystatin 100000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream
  • RxCUI: 1053753 - nystatin 100,000 UNT/ML / triamcinolone acetonide 1 MG/ML Topical Cream

Clinical Specifications

Proprietary Name
Nystatin And Triamcinolone Acetonide
Non-Proprietary Name
Nystatin And Triamcinolone Acetonide
Substance Name
Nystatin; Triamcinolone Acetonide
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)
Pharmacologic Class
Usage Information
Nystatin and Triamcinolone Acetonide Cream USP 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
Lupin Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA208205
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-29-2018
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 (68180-545). Click a package code to view its specific billing and regulatory data.

68180-545-02
1 TUBE in 1 CARTON / 30 g in 1 TUBE
68180-545-03
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 68180-545-01 identifies a specific commercial package of 1 tube in 1 carton / 15 g in 1 tube of Nystatin And Triamcinolone Acetonide, a human prescription drug labeled by Lupin Pharmaceuticals, Inc.. This cream is formulated for topical use and contains nystatin; triamcinolone acetonide 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 Lupin Pharmaceuticals, Inc. on November 29, 2018. The current certification is valid through December 31, 2026.

How is this Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68180054501. 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)
68180-545-01
11-Digit CMS (5-4-2)
68180-0545-01

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