Medicine
Halobetasol propionate 0.05% ointment
Halobetasol propionate 0.05% ointment is a generic prescription medicine for topical use, made by 5 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store between 15°C and 30°C (59°F and 86°F).
Key facts
- Active ingredient (INN)
- Halobetasol propionate
- Brand
- Sold under the generic name
- Strength
- 0.05%
- Dosage form
- Ointment
- Route
- Topical
- Packs
- 1 tube and 12 more
- Manufacturers
- Bryant Ranch PrepackCosette PharmaceuticalsEncube EthicalsPadagis Israel PharmaceuticalsQuagen Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store between 15°C and 30°C (59°F and 86°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D07AC21 Halobetasol propionate
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 June 2005
- Identifiers
- RxCUI 977978DailyMed set ID be683823-9c07-498c-8357-71cbb3a3964c, c4e78fa5-6ced-4c90-89c6-31e5fc71b837, 83725d7b-0788-4903-a75a-8e318ee7b568 +6NDC 72162-1396, 72162-2067, 63629-8665 +6Application ANDA076872, ANDA213560, ANDA209978 +1
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tube in 1 carton / 15 g in 1 tube | 0713-0339-15 | Cosette Pharmaceuticals | 21 February 2018 |
| 1 tube in 1 carton / 50 g in 1 tube | 0713-0339-86 | Cosette Pharmaceuticals | 21 February 2018 |
| 1 tube in 1 carton / 15 g in 1 tube | 21922-108-04 | Encube Ethicals | 1 July 2026 |
| 1 tube in 1 carton / 50 g in 1 tube | 21922-108-14 | Encube Ethicals | 1 July 2026 |
| 1 tube in 1 carton / 50 g in 1 tube | 45802-131-32 | Padagis Israel Pharmaceuticals | 5 February 2009 |
| 1 tube in 1 carton / 15 g in 1 tube | 45802-131-35 | Padagis Israel Pharmaceuticals | 14 January 2010 |
| 1 tube in 1 carton / 15 g in 1 tube | 70752-119-02 | Quagen Pharmaceuticals | 6 October 2020 |
| 1 tube in 1 carton / 50 g in 1 tube | 70752-119-04 | Quagen Pharmaceuticals | 6 October 2020 |
| 1 tube in 1 carton / 15 g in 1 tube | 63629-8664-1 | Bryant Ranch Prepack | 14 January 2010 |
| 1 tube in 1 carton / 50 g in 1 tube | 63629-8665-1 | Bryant Ranch Prepack | 5 February 2009 |
| 1 tube in 1 carton / 15 g in 1 tube | 72162-1396-2 | Bryant Ranch Prepack | 11 March 2024 |
| 1 tube in 1 carton / 50 g in 1 tube | 72162-1396-4 | Bryant Ranch Prepack | 11 March 2024 |
| 1 tube in 1 carton / 15 g in 1 tube | 72162-2067-2 | Bryant Ranch Prepack | 15 August 2023 |
| 1 tube in 1 carton / 50 g in 1 tube | 72162-2067-4 | Bryant Ranch Prepack | 15 August 2023 |
| 1 tube in 1 carton / 50 g in 1 tube | 72162-2258-2 | Bryant Ranch Prepack | 21 February 2018 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 17 December 1990 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Halobetasol propionate
Clinical summary
Halobetasol propionate is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. It is available as ointment, cream and lotion for topical use. MedsAcross supplies Halobetasol propionate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Halobetasol propionateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Halobetasol Propionate prescribing information (Coral Way Pharma) · U.S. National Library of Medicine, DailyMed
Need Halobetasol propionate 0.05% ointment for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.