Triamcinolone Acetonide Ointment
NDC Package 33342-331-80

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

Triamcinolone Acetonide ointment is a medication used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). This formulation utilizes a ointment delivery system. Marketed by Macleods Pharmaceuticals Limited, this product is identified by NDC 33342-331 and is authorized under FDA application ANDA209828.

Identification & Billing

NDC Package Code
33342-331-80
Package Description
1 TUBE in 1 CARTON / 80 g in 1 TUBE
Product Code
33342-331
11-Digit Billing Format
33342033180
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
80 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Triamcinolone Acetonide
Non-Proprietary Name
Triamcinolone Acetonide
Substance Name
Triamcinolone Acetonide
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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)
TRIAMCINOLONE ACETONIDE .25 mg/g
Pharmacologic Class
Usage Information
This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Triamcinolone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium- to strong-potency corticosteroid. The potency depends on the strength and the form that you use. For details on the potency of your product, ask your pharmacist.

Regulatory & Marketing

Labeler Name
Macleods Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA209828
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-23-2018
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 (33342-331). Click a package code to view its specific billing and regulatory data.

33342-331-15
1 TUBE in 1 CARTON / 15 g in 1 TUBE
33342-331-54
454 g in 1 JAR

* 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 33342-331-80 identifies a specific commercial package of 1 tube in 1 carton / 80 g in 1 tube of Triamcinolone Acetonide, a human prescription drug labeled by Macleods Pharmaceuticals Limited. This ointment is formulated for topical use and contains 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 Macleods Pharmaceuticals Limited on November 23, 2018. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Triamcinolone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium- to strong-potency corticosteroid. The potency depends on the strength and the form that you use. For details on the potency of your product, ask your pharmacist.

How is this Macleods Pharmaceuticals Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33342033180. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 80 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)
33342-331-80
11-Digit CMS (5-4-2)
33342-0331-80

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