Prescription medicine
Halobetasol and tazarotene Brand names: Duobrii
Halobetasol and tazarotene (Duobrii) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the halobetasol and tazarotene FDA label on DailyMed (effective January 1, 2020, Bausch Health US, LLC); the NDA 209354 record on Drugs@FDA; every halobetasol and tazarotene label on DailyMed.
Highlights of the record
FDA label of January 1, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDUOBRII ® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults.
Forms and strengths
- 0.1 mg/g / 0.45 mg/g
Lotion.
On the market
- Earliest approval on file
- April 25, 2019 Duobrii, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first May 2, 2025; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 6, 2036 Duobrii lotion; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 198 through July 30, 2026
What is halobetasol and tazarotene used for?
From the label: indications and usageDUOBRII ® (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is indicated for the topical treatment of plaque psoriasis in adults. DUOBRII Lotion is a combination of halobetasol propionate and tazarotene indicated for the topical treatment of plaque psoriasis in adults.
Conditions named in the indications of halobetasol and tazarotene's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Corticosteroid and Retinoid.
Source: FDA drug label (Duobrii), Bausch Health US, LLC, effective January 1, 2020 (SPL set b3f0cdc0-69fd-43d1-baf2-d776a3a20715), via openFDA; the full label on DailyMed
What does the patient leaflet for halobetasol and tazarotene say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DUOBRII?DUOBRII may cause birth defects if used during pregnancy. Females must not be pregnant when they start using DUOBRII or become pregnant during treatment with DUOBRII. • For females who are able to get pregnant: • Your healthcare provider will order a pregnancy test for you within 2 weeks before you begin treatment with DUOBRII to be sure that you are not pregnant. Your healthcare provider will decide when to do the test. • Begin treatment with DUOBRII during a normal menstrual period. • Use an effective form of birth control during treatment with DUOBRII. Talk with your healthcare provider about birth control options that may be used to prevent pregnancy during treatment with DUOBRII. • Stop using DUOBRII and tell your healthcare provider right away if you become pregnant during treatment with DUOBRII.
From the patient leaflet: What should I avoid during treatment with DUOBRII?Avoid sunlight, including sunlamps and tanning beds during your treatment with DUOBRII. DUOBRII can make your skin more sensitive to the sun and the light from sunlamps and tanning beds. You could get severe sunburn. Use sunscreen, and wear a hat and clothes that cover your skin if you have to be in sunlight. • Talk to your healthcare provider if you get sunburn during treatment with DUOBRII. If you do get sunburn, do not use DUOBRII until your sunburn is healed. • Avoid using DUOBRII on skin with eczema because it may cause severe irritation.
From the patient leaflet: How should I store DUOBRII?Store DUOBRII at room temperature between 68°F to 77°F (20°C to 25°C). • Protect from freezing. Keep DUOBRII and all medicines out of the reach of children.
Source: FDA drug label (Duobrii), Bausch Health US, LLC, effective January 1, 2020 (SPL set b3f0cdc0-69fd-43d1-baf2-d776a3a20715), via openFDA; the full label on DailyMed
Is there a generic for halobetasol and tazarotene (Duobrii)?
The FDA approved the first generic halobetasol and tazarotene on May 2, 2025. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 10 patents for Duobrii lotion, the last expiring on June 6, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2025 first generic approved
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for halobetasol and tazarotene?
The FDA Adverse Event Reporting System holds 198 reports that list halobetasol and tazarotene among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 13 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as halobetasol and tazarotene?
9 other medicines are given the same way (topical) and in the same FDA class as halobetasol and tazarotene or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Clobetasol | Psoriasis | 40 labelers | $0.126 per gram 0.05% ointment | No current entry |
| Betamethasone | Psoriasis | 26 labelers | $0.418 per gram 0.05% cream | No current entry |
| Fluocinolone | Psoriasis | 15 labelers | $0.171 per mL 0.01% scalp oil | No current entry |
| Desoximetasone | Psoriasis | 13 labelers | $0.369 per gram 0.25% ointment | No current entry |
| Betamethasone and calcipotriene | Psoriasis | 5 labelers | $1.81 per gram 0.005%-0.064% ointment | No current entry |
| Coal tar | Psoriasis | none listed | $0.0088 per mL 0.5% shampoo | No current entry |
| Calcipotriene | Psoriasis | 6 labelers | $1.05 per gram 0.005% cream | No current entry |
| Calcitriol | Psoriasis | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as halobetasol and tazarotene
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to halobetasol and tazarotene
- 9 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Halobetasol and tazarotene side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other