Prescription medicine
Halobetasol Brand names: Bryhali, Ultravate, Lexette
Halobetasol (Ultravate) is a prescription medicine with an FDA approval on record since 1990. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $0.620 per gram (Halobetasol prop 0.05% ointmnt) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the halobetasol FDA label on DailyMed (effective June 29, 2026, Encube Ethicals, Inc.); the NDA 19968 record on Drugs@FDA; every halobetasol label on DailyMed.
Highlights of the record
FDA label of June 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageHalobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Forms and strengths
- 0.1 mg/g
- 0.5 mg/g
Ointment; lotion; cream; aerosol (foam).
On the market
- Earliest approval on file
- December 17, 1990 Ultravate, Sun Pharm Inds Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first December 16, 2004; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 6 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- June 19, 2033 Ultravate lotion; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.620 per gram Halobetasol prop 0.05% ointmnt
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2022 0 Class I among all firms' recalls; latest March 15, 2022
- FAERS reports
- 1,336 through July 30, 2026
What is halobetasol used for?
From the label: indications and usageHalobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Treatment beyond two consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in children under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Conditions named in the indications of halobetasol's FDA labels, with every medicine labeled for each:
From other halobetasol labelsPsoriasis: Halobetasol Propionate Lotion 0.05% is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
FDA pharmacologic class: Corticosteroid.
Source: FDA drug label (Halobetasol Propionate), Encube Ethicals, Inc., effective June 29, 2026 (SPL set d4f03a79-3d5e-4a39-8ab0-8ebd3d804e39), via openFDA; the full label on DailyMed
Is there a generic for halobetasol (Ultravate)?
The FDA approved the first generic halobetasol on December 16, 2004. 13 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists halobetasol from 6 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Ultravate lotion, the last expiring on June 19, 2033; a patent listed only for Lexette aerosol runs to May 30, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1990 earliest approval on file
- 2004 first generic approved
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for halobetasol (Ultravate)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.620 per gram (Halobetasol prop 0.05% ointmnt), down 8% from $0.673 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Halobetasol prop 0.05% ointmnt (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Halobetasol prop 0.05% cream | Generic | $0.528 per gram | n/a | -6% |
| Halobetasol prop 0.05% ointmnt | Generic | $0.620 per gram | n/a | -8% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has halobetasol been recalled?
The FDA's Enforcement Report lists 3 recalls naming halobetasol since 2022: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2022 | Class II | Teligent Pharma, Inc. | cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for halobetasol?
The FDA Adverse Event Reporting System holds 1,336 reports that list halobetasol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 28 are coded as a death and 176 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.
Reports received each year
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?
10 other medicines are given the same way (topical) and in the same FDA class as halobetasol 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 |
| Tazarotene | Psoriasis | 6 labelers | $6.11 per gram 0.1% gel | No current entry |
| Calcipotriene | Psoriasis | 6 labelers | $1.05 per gram 0.005% cream | No current entry |
Every medicine labeled for the same conditions as halobetasol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does halobetasol compare with medicines for the same use?
2 side-by-side pages set halobetasol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to halobetasol
- 10 medicines for the same use
- Other corticosteroids
- the pharmacologic class, with prices and generics
- Halobetasol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other