Medicine
Clobetasol propionate 0.05% cream
Clobetasol propionate 0.05% cream is a generic prescription medicine for topical use, made by 15 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. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Clobetasol propionate cream should not refrigerated. Store cream between 15°…
Key facts
- Active ingredient (INN)
- Clobetasol propionate
- Brand
- Sold under the generic name
- Strength
- 0.05%
- Dosage form
- Cream
- Route
- Topical
- Packs
- 1 tube, 15 g, 30 g and 63 more
- Manufacturers
- Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaLupinIndiaTorrent PharmaceuticalsIndiaBryant Ranch PrepackAmneal PharmaceuticalsEncube EthicalsXiromed15 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Clobetasol propionate cream should not refrigerated. Store cream between 15° and 30°C (59°-86°F).
- Cold chain
- Yes, shipped temperature controlled
- 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
- 8 July 1996
- Identifiers
- RxCUI 861495, 861434, 861448 +1DailyMed set ID 2a356447-46d2-40cc-b850-f387982c517a, 6f52ac0f-4028-4733-9ef6-e5ce5468b384, bcb76b4b-194d-4cb3-b3ed-26b911df1a11 +26NDC 72603-323, 82804-133, 21922-016 +26Application ANDA212982, ANDA210208, ANDA213291 +6
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
A sample of 40 packs from 15 labelers. The register lists 66 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 tube in 1 carton / 15 g in 1 tube | 46708-547-15 | Alembic PharmaceuticalsIndia | 26 March 2025 |
| 1 tube in 1 carton / 30 g in 1 tube | 46708-547-30 | Alembic PharmaceuticalsIndia | 26 March 2025 |
| 1 tube in 1 carton / 45 g in 1 tube | 46708-547-45 | Alembic PharmaceuticalsIndia | 26 March 2025 |
| 1 tube in 1 carton / 60 g in 1 tube | 46708-547-60 | Alembic PharmaceuticalsIndia | 26 March 2025 |
| 1 tube in 1 carton / 15 g in 1 tube | 62332-547-15 | Alembic PharmaceuticalsIndia | 31 January 2020 |
| 1 tube in 1 carton / 30 g in 1 tube | 62332-547-30 | Alembic PharmaceuticalsIndia | 31 January 2020 |
| 1 tube in 1 carton / 45 g in 1 tube | 62332-547-45 | Alembic PharmaceuticalsIndia | 31 January 2020 |
| 1 tube in 1 carton / 60 g in 1 tube | 62332-547-60 | Alembic PharmaceuticalsIndia | 31 January 2020 |
| 1 tube in 1 carton / 15 g in 1 tube | 51672-1258-1 | Sun Pharmaceutical IndustriesIndia | 8 July 1996 |
| 1 tube in 1 carton / 30 g in 1 tube | 51672-1258-2 | Sun Pharmaceutical IndustriesIndia | 8 July 1996 |
| 1 tube in 1 carton / 60 g in 1 tube | 51672-1258-3 | Sun Pharmaceutical IndustriesIndia | 8 July 1996 |
| 1 tube in 1 carton / 45 g in 1 tube | 51672-1258-6 | Sun Pharmaceutical IndustriesIndia | 8 July 1996 |
| 1 tube in 1 carton / 15 g in 1 tube | 51672-1297-1 | Sun Pharmaceutical IndustriesIndia | 17 May 2000 |
| 1 tube in 1 carton / 30 g in 1 tube | 51672-1297-2 | Sun Pharmaceutical IndustriesIndia | 17 May 2000 |
| 1 tube in 1 carton / 60 g in 1 tube | 51672-1297-3 | Sun Pharmaceutical IndustriesIndia | 17 May 2000 |
| 1 tube in 1 carton / 15 g in 1 tube | 68180-956-01 | LupinIndia | 17 August 2018 |
| 1 tube in 1 carton / 30 g in 1 tube | 68180-956-02 | LupinIndia | 17 August 2018 |
| 1 tube in 1 carton / 45 g in 1 tube | 68180-956-03 | LupinIndia | 17 August 2018 |
| 1 tube in 1 carton / 60 g in 1 tube | 68180-956-04 | LupinIndia | 17 August 2018 |
| 15 g in 1 tube | 13668-569-01 | Torrent PharmaceuticalsIndia | 15 December 2024 |
| 30 g in 1 tube | 13668-569-02 | Torrent PharmaceuticalsIndia | 15 December 2024 |
| 45 g in 1 tube | 13668-569-04 | Torrent PharmaceuticalsIndia | 15 December 2024 |
| 60 g in 1 tube | 13668-569-05 | Torrent PharmaceuticalsIndia | 15 December 2024 |
| 1 tube in 1 carton / 30 g in 1 tube | 69238-1532-3 | Amneal Pharmaceuticals | 28 December 2018 |
| 1 tube in 1 carton / 45 g in 1 tube | 69238-1532-4 | Amneal Pharmaceuticals | 28 December 2018 |
| 1 tube in 1 carton / 15 g in 1 tube | 69238-1532-5 | Amneal Pharmaceuticals | 28 December 2018 |
| 1 tube in 1 carton / 60 g in 1 tube | 69238-1532-6 | Amneal Pharmaceuticals | 28 December 2018 |
| 15 g in 1 tube | 21922-016-04 | Encube Ethicals | 1 October 2020 |
| 30 g in 1 tube | 21922-016-05 | Encube Ethicals | 1 October 2020 |
| 45 g in 1 tube | 21922-016-06 | Encube Ethicals | 1 October 2020 |
| 60 g in 1 tube | 21922-016-07 | Encube Ethicals | 1 October 2020 |
| 1 tube in 1 carton / 15 g in 1 tube | 70700-109-15 | Xiromed | 19 June 2018 |
| 1 tube in 1 carton / 30 g in 1 tube | 70700-109-16 | Xiromed | 19 June 2018 |
| 1 tube in 1 carton / 60 g in 1 tube | 70700-109-17 | Xiromed | 19 June 2018 |
| 1 tube in 1 carton / 45 g in 1 tube | 70700-109-18 | Xiromed | 19 June 2018 |
| 60 g in 1 tube | 63629-2329-1 | Bryant Ranch Prepack | 19 April 2021 |
| 1 tube in 1 carton / 45 g in 1 tube | 63629-2330-1 | Bryant Ranch Prepack | 19 April 2021 |
| 1 tube in 1 carton / 30 g in 1 tube | 63629-2331-1 | Bryant Ranch Prepack | 19 April 2021 |
| 1 tube in 1 carton / 15 g in 1 tube | 63629-2332-1 | Bryant Ranch Prepack | 19 April 2021 |
| 60 g in 1 tube | 71335-2821-1 | Bryant Ranch Prepack | 22 October 2025 |
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
Alternatives
Other makers and brands of Clobetasol propionate 0.05% cream.
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% cream 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.