Quick answers
- What is Halobetasol propionate used for?
- The FDA-approved label (Ultravate, Lacer Pharma, LLC, April 6, 2025) says: “ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. ULTRAVATE lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Halobetasol propionate have a boxed warning?
- No. None of the 17 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Halobetasol propionate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Halobetasol propionate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Halobetasol propionate?
- 9 companies list prescription products of Halobetasol propionate in the FDA NDC Directory, including Bryant Ranch Prepack, Padagis Israel Pharmaceuticals Ltd and Cosette Pharmaceuticals, Inc..
What Halobetasol propionate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. ULTRAVATE lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
— FDA label: Ultravate, Lacer Pharma, LLC, effective April 6, 2025. Read the full label on DailyMed →
The FDA has 17 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 17 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| halobetasol propionate 0.05% cream | Generic | $0.4053–$0.6278 per gram 4 packages, lowest to highest |
| halobetasol propionate 0.05% ointment | Generic | $0.3759–$0.7940 per gram 6 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack6 products
- Padagis Israel Pharmaceuticals Ltd2 products
- Cosette Pharmaceuticals, Inc.2 products
- Mayne Pharma2 products
- Bausch Health US, LLC1 product
- Encube Ethicals, Inc.1 product
- Quagen Pharmaceuticals LLC1 product
- Lacer Pharma, LLC1 product
- Coral Way Pharma, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208183 ULTRAVATE | Lacer Pharma | November 6, 2015 | 1, latest August 27, 2020 2020: Efficacy |
| NDA209355 BRYHALI | Bausch | November 6, 2018 | — |
Generic approvals (7)
- ANDA076872Padagis Israel · December 16, 2004
- ANDA077123Padagis Israel · December 16, 2004
- ANDA077109Cosette Pharms Nc · June 14, 2005
- ANDA078162Cosette Pharms Nc · April 24, 2007
- ANDA209978Encube · March 20, 2018
- ANDA213560Quagen · October 6, 2020
- ANDA215266Padagis Israel · August 11, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ultravate, Lacer Pharma, LLC, effective April 6, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →