Medicine
Betamethasone dipropionate 0.5 mg/mL lotion
Betamethasone dipropionate 0.5 mg/mL lotion is a generic prescription medicine for topical use, made by 4 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
Protect from light and freezing. Store at 25°C, excursions permitted between…
Key facts
- Active ingredient (INN)
- Betamethasone dipropionate
- Brand
- Sold under the generic name
- Strength
- 0.5 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Packs
- 1 bottle, 30 mL, 60 mL and 5 more
- Manufacturers
- Sun Pharmaceutical IndustriesIndiaE. FougeraEncube EthicalsCosette Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Protect from light and freezing. Store at 25°C, excursions permitted between 15° and 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
- 12 August 1985
- Identifiers
- RxCUI 238920, 240209, 848178DailyMed set ID 97dde5f5-a865-4af2-b562-8da72c8475f3, 3b23a3c0-3306-4a2d-932d-25916d16dc68, 7e946599-2fb4-4426-bb59-fbb71d89dac8 +2NDC 0168-0057, 51672-1340, 21922-104 +2Application ANDA070275, ANDA077477, ANDA206389 +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 / 30 mL in 1 bottle | 51672-1340-3 | Sun Pharmaceutical IndustriesIndia | 21 May 2007 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 51672-1340-4 | Sun Pharmaceutical IndustriesIndia | 21 May 2007 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 0168-0057-60 | E. Fougera | 12 August 1985 |
| 30 mL in 1 bottle | 0168-0267-30 | E. Fougera | 21 May 2007 |
| 60 mL in 1 bottle | 0168-0267-60 | E. Fougera | 21 May 2007 |
| 1 bottle in 1 carton / 60 mL in 1 bottle | 0713-0807-53 | Cosette Pharmaceuticals | 5 September 2016 |
| 1 bottle, plastic in 1 carton / 60 mL in 1 bottle, plastic | 21922-104-01 | Encube Ethicals | 25 November 2025 |
| 1 bottle, plastic in 1 carton / 30 mL in 1 bottle, plastic | 21922-104-21 | Encube Ethicals | 25 November 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 29 January 1975 | 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 Betamethasone dipropionate
Clinical summary
Betamethasone dipropionate is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. MedsAcross supplies Betamethasone dipropionate 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 Betamethasone dipropionateFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Betamethasone Dipropionate prescribing information (Prasco Laboratories) · U.S. National Library of Medicine, DailyMed
Need Betamethasone dipropionate 0.5 mg/mL lotion 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.