Medicine
Clobetasol propionate 0.5 mg/mL topical solution
Clobetasol propionate 0.5 mg/mL topical solution is a generic prescription medicine for topical use, made by 10 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 at 20 o to 25 • C (68 o to 77 • F).
Key facts
- Active ingredient (INN)
- Clobetasol propionate
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 1 bottle, 50 mL and 15 more
- Manufacturers
- Alembic PharmaceuticalsIndiaMicro LabsIndiaSun Pharmaceutical IndustriesIndiaLupinIndiaNovel LaboratoriesIndiaEncube EthicalsGolden State Medical SupplyQuagen PharmaceuticalsA-S Medication SolutionsE. Fougera
- Origin register
- US FDA, United States
- Storage
- Store at 20 o to 25 • C (68 o to 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
- 16 November 1998
- Identifiers
- RxCUI 861487DailyMed set ID c6efb5f3-3532-4742-a359-3991bb76338f, 85aea21d-c4ff-4558-b416-516fa93bea1f, 04180cdf-c63a-d524-e063-6394a90a2d06 +8NDC 43386-028, 42571-362, 51407-737 +8Application ANDA206075, ANDA211494, ANDA075224 +4
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 bottle in 1 carton / 25 mL in 1 bottle | 46708-486-25 | Alembic PharmaceuticalsIndia | 17 March 2025 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 46708-486-50 | Alembic PharmaceuticalsIndia | 17 March 2025 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 62332-486-25 | Alembic PharmaceuticalsIndia | 24 October 2019 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 62332-486-50 | Alembic PharmaceuticalsIndia | 24 October 2019 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 43386-028-60 | LupinIndia | 23 November 2015 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 42571-362-81 | Micro LabsIndia | 2 October 2019 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 42571-362-99 | Micro LabsIndia | 2 October 2019 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 40032-028-60 | Novel LaboratoriesIndia | 23 November 2015 |
| 1 bottle, plastic in 1 carton / 25 mL in 1 bottle, plastic | 51672-1293-2 | Sun Pharmaceutical IndustriesIndia | 16 November 1998 |
| 1 bottle, plastic in 1 carton / 50 mL in 1 bottle, plastic | 51672-1293-3 | Sun Pharmaceutical IndustriesIndia | 16 November 1998 |
| 50 mL in 1 bottle, plastic | 0168-0269-50 | E. Fougera | 8 February 1999 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 21922-061-22 | Encube Ethicals | 10 June 2024 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 21922-061-27 | Encube Ethicals | 10 June 2024 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 70752-153-04 | Quagen Pharmaceuticals | 14 March 2022 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 70752-153-20 | Quagen Pharmaceuticals | 14 March 2022 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 50090-5264-0 | A-S Medication Solutions | 16 October 2020 |
| 1 bottle in 1 carton / 25 mL in 1 bottle | 51407-737-25 | Golden State Medical Supply | 29 August 2023 |
| 1 bottle in 1 carton / 50 mL in 1 bottle | 51407-737-50 | Golden State Medical Supply | 29 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 0.5 mg/mL topical solution 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.