Duobrii Lotion
NDC Package 0187-0653-01

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

Duobrii (halobetasol propionate and tazarotene) lotions is a medication a combination product used to treat a certain skin condition (psoriasis). This formulation utilizes a lotion delivery system. Marketed by Bausch Health Us, Llc, this product is identified by NDC 0187-0653 and is authorized under FDA application NDA209354.

Identification & Billing

NDC Package Code
0187-0653-01
Package Description
1 TUBE in 1 CARTON / 100 g in 1 TUBE
Product Code
0187-0653
11-Digit Billing Format
00187065301
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
100 GM
RxNorm Crosswalk
  • RxCUI: 2166089 - halobetasol propionate 0.01 % / tazarotene 0.045 % Topical Lotion
  • RxCUI: 2166089 - halobetasol propionate 0.1 MG/ML / tazarotene 0.45 MG/ML Topical Lotion
  • RxCUI: 2166094 - Duobrii 0.01 % / 0.045 % Topical Lotion
  • RxCUI: 2166094 - halobetasol propionate 0.1 MG/ML / tazarotene 0.45 MG/ML Topical Lotion [Duobrii]

Clinical Specifications

Proprietary Name
Duobrii
Non-Proprietary Name
Halobetasol Propionate And Tazarotene
Substance Name
Halobetasol Propionate; Tazarotene
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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 medication is a combination product used to treat a certain skin condition (psoriasis). It contains 2 ingredients: halobetasol and tazarotene. Halobetasol is a very strong (super-high potency) corticosteroid. It helps reduce the itching, redness, scaling, and swelling that can occur with this condition. Tazarotene is a retinoid product (related to vitamin A) that works by affecting the growth of skin cells.

Regulatory & Marketing

Labeler Name
Bausch Health Us, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA209354
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-25-2019
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 (0187-0653). Click a package code to view its specific billing and regulatory data.

0187-0653-03
6 TUBE in 1 CARTON / 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 0187-0653-01 identifies a specific commercial package of 1 tube in 1 carton / 100 g in 1 tube of Duobrii, a human prescription drug labeled by Bausch Health Us, Llc. This lotion is formulated for topical use and contains halobetasol propionate; tazarotene 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 Bausch Health Us, Llc on April 25, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a combination product used to treat a certain skin condition (psoriasis). It contains 2 ingredients: halobetasol and tazarotene. Halobetasol is a very strong (super-high potency) corticosteroid. It helps reduce the itching, redness, scaling, and swelling that can occur with this condition. Tazarotene is a retinoid product (related to vitamin A) that works by affecting the growth of skin cells.

How is this Bausch Health Us, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00187065301. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 100 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)
0187-0653-01
11-Digit CMS (5-4-2)
00187-0653-01

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