Medicine
Clobetasol propionate 0.05% gel
Clobetasol propionate 0.05% gel is a generic prescription medicine for topical use, made by 3 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
Clobetasol Propionate Gel, 0.05% should not be refrigerated. Store at 20-25°C…
Key facts
- Active ingredient (INN)
- Clobetasol propionate
- Brand
- Sold under the generic name
- Strength
- 0.05%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 tube and 9 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaBryant Ranch PrepackPadagis Israel Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Clobetasol Propionate Gel, 0.05% should not be refrigerated. Store at 20-25°C (68-77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.32Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 May 1999
- Identifiers
- RxCUI 861434, 861448, 861495DailyMed set ID f9df643a-015d-4101-ac8f-c1e05b052df5, bc021c6c-43db-469c-b1c3-0166b18daea4, 1bdc1978-00d1-43f4-a127-a9d9c709644d +3NDC 45802-925, 63629-8637, 63629-8639 +3Application ANDA075027, ANDA075279
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 | 51672-1294-1 | Sun Pharmaceutical IndustriesIndia | 28 May 1999 |
| 1 tube in 1 carton / 30 g in 1 tube | 51672-1294-2 | Sun Pharmaceutical IndustriesIndia | 28 May 1999 |
| 1 tube in 1 carton / 60 g in 1 tube | 51672-1294-3 | Sun Pharmaceutical IndustriesIndia | 28 May 1999 |
| 1 tube in 1 carton / 15 g in 1 tube | 45802-925-14 | Padagis Israel Pharmaceuticals | 30 July 2008 |
| 1 tube in 1 carton / 30 g in 1 tube | 45802-925-94 | Padagis Israel Pharmaceuticals | 11 November 2008 |
| 1 tube in 1 carton / 60 g in 1 tube | 45802-925-96 | Padagis Israel Pharmaceuticals | 31 July 2008 |
| 1 tube in 1 carton / 15 g in 1 tube | 63629-8637-1 | Bryant Ranch Prepack | 30 July 2008 |
| 1 tube in 1 carton / 30 g in 1 tube | 63629-8638-1 | Bryant Ranch Prepack | 11 November 2008 |
| 1 tube in 1 carton / 60 g in 1 tube | 63629-8639-1 | Bryant Ranch Prepack | 31 July 2008 |
| 1 tube in 1 carton / 15 g in 1 tube | 72162-1438-2 | Bryant Ranch Prepack | 16 August 2023 |
| 1 tube in 1 carton / 30 g in 1 tube | 72162-1438-3 | Bryant Ranch Prepack | 16 August 2023 |
| 1 tube in 1 carton / 60 g in 1 tube | 72162-1438-6 | Bryant Ranch Prepack | 16 August 2023 |
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 27 December 1985 | 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 Clobetasol propionate
Clinical summary
Clobetasol propionate is a corticosteroid indicated for the treatment of moderate to severe scalp psoriasis in subjects 18 years of age and older, among other approved uses. MedsAcross supplies Clobetasol 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 Clobetasol 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
- clobetasol propionate prescribing information (Mayne Pharma) · U.S. National Library of Medicine, DailyMed
Need Clobetasol propionate 0.05% gel 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.