Tri-luma Cream
NDC Package 0299-5950-30

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

Tri-luma (fluocinolone acetonide, hydroquinone, and tretinoin) cream is this combination medication is used to treat melasma on the face. This formulation utilizes a cream delivery system. Marketed by Galderma Laboratories, L.p., this product is identified by NDC 0299-5950 and is authorized under FDA application NDA021112.

Identification & Billing

NDC Package Code
0299-5950-30
Package Description
1 TUBE in 1 CARTON / 30 g in 1 TUBE
Product Code
0299-5950
11-Digit Billing Format
00299595030
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
30 GM
RxNorm Crosswalk
  • RxCUI: 1191262 - fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % Topical Cream
  • RxCUI: 1191262 - fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream
  • RxCUI: 1191264 - Tri-Luma 0.01 % / 4 % / 0.05 % Topical Cream
  • RxCUI: 1191264 - fluocinolone acetonide 0.1 MG/ML / hydroquinone 40 MG/ML / tretinoin 0.5 MG/ML Topical Cream [Tri-Luma]
  • RxCUI: 1191264 - Tri-Luma (fluocinolone acetonide 0.01 % / hydroquinone 4 % / tretinoin 0.05 % ) Topical Cream

Clinical Specifications

Proprietary Name
Tri-luma
Non-Proprietary Name
Fluocinolone Acetonide, Hydroquinone, And Tretinoin
Substance Name
Fluocinolone Acetonide; Hydroquinone; Tretinoin
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
This combination medication is used to treat melasma on the face. Melasma is a condition of dark patchy areas on the skin, especially on the cheeks and forehead. It sometimes occurs with hormone changes. This product contains 3 different kinds of medication. Hydroquinone is a reversible skin bleaching agent. Tretinoin is a retinoid that increases skin shedding. Fluocinolone is a medium strength corticosteroid that reduces swelling, itching, and redness. This medication may improve your melasma, but it is not a cure. Continued exposure to some of the causes of melasma (e.g., sunlight, estrogen-type birth control hormones) may cause it to return.

Regulatory & Marketing

Labeler Name
Galderma Laboratories, L.p.
Product Type
Human Prescription Drug
FDA Application #
NDA021112
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-18-2002
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 (0299-5950). Click a package code to view its specific billing and regulatory data.

0299-5950-02
1 TUBE in 1 BLISTER PACK / 3 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 0299-5950-30 identifies a specific commercial package of 1 tube in 1 carton / 30 g in 1 tube of Tri-luma, a human prescription drug labeled by Galderma Laboratories, L.p.. This cream is formulated for topical use and contains fluocinolone acetonide; hydroquinone; tretinoin 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 Galderma Laboratories, L.p. on January 18, 2002. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This combination medication is used to treat melasma on the face. Melasma is a condition of dark patchy areas on the skin, especially on the cheeks and forehead. It sometimes occurs with hormone changes. This product contains 3 different kinds of medication. Hydroquinone is a reversible skin bleaching agent. Tretinoin is a retinoid that increases skin shedding. Fluocinolone is a medium strength corticosteroid that reduces swelling, itching, and redness. This medication may improve your melasma, but it is not a cure. Continued exposure to some of the causes of melasma (e.g., sunlight, estrogen-type birth control hormones) may cause it to return.

How is this Galderma Laboratories, L.p. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00299595030. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 30 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 (4-4-2)
0299-5950-30
11-Digit CMS (5-4-2)
00299-5950-30

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