Medicine
Clobetasol propionate 0.05 g/100 mL shampoo
Clobetasol propionate 0.05 g/100 mL shampoo is a generic prescription medicine for topical use, made by 7 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 USP controlled room temperature 68˚ to 77˚F (20˚ to 25˚C), with…
Key facts
- Active ingredient (INN)
- Clobetasol propionate
- Brand
- Sold under the generic name
- Strength
- 0.05 g/100 mL
- Dosage form
- Shampoo
- Route
- Topical
- Packs
- 1 bottle, 118 mL and 6 more
- Manufacturers
- Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaBryant Ranch PrepackAmneal Pharmaceuticals NYMayne PharmaNorthStar RxPadagis Israel Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at USP controlled room temperature 68˚ to 77˚F (20˚ to 25˚C), with excursions permitted between 59˚ and 86˚F (15˚ to 30˚C).
- 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
- 10 August 2012
- Identifiers
- RxCUI 861490DailyMed set ID 2b7f0643-679c-4586-a3a0-31eae4a36f19, 04d7d65b-d7ed-4223-abab-5d0aed36a155, 40c3b94f-a61c-4fc1-a411-5bf4e3fe6791 +6NDC 46708-548, 51672-1347, 63629-9461 +6Application ANDA213290, ANDA214867, ANDA090974 +2
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 / 118 mL in 1 bottle | 46708-548-04 | Alembic PharmaceuticalsIndia | 18 March 2025 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 62332-548-04 | Alembic PharmaceuticalsIndia | 26 May 2020 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 51672-1347-8 | Sun Pharmaceutical IndustriesIndia | 25 March 2021 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 69238-1732-8 | Amneal Pharmaceuticals NY | 15 June 2021 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 68308-664-04 | Mayne Pharma | 3 November 2023 |
| 118 mL in 1 bottle | 45802-961-26 | Padagis Israel Pharmaceuticals | 10 August 2012 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 63629-9461-1 | Bryant Ranch Prepack | 31 October 2022 |
| 118 mL in 1 bottle | 72162-1442-2 | Bryant Ranch Prepack | 2 April 2025 |
| 1 bottle in 1 carton / 118 mL in 1 bottle | 16714-030-01 | Northstar RX | 28 March 2021 |
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 g/100 mL shampoo 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.