Medicine
Betamethasone dipropionate 0.05% ointment
Betamethasone dipropionate 0.05% ointment is a generic prescription medicine for topical use, made by 12 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
- 0.05%
- Dosage form
- Ointment
- Route
- Topical
- Packs
- 1 tube, 15 g, 50 g and 30 more
- Manufacturers
- Aurobindo PharmaIndiaLupinIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaBryant Ranch PrepackActavis PharmaE. FougeraA-S Medication SolutionsBurel PharmaceuticalsPadagis Israel 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
- 4 September 1984
- Identifiers
- RxCUI 848180, 197405DailyMed set ID b5291e39-40a0-4362-9281-97f5fb4025d9, 0173ed23-9f7c-466e-9eba-f6859d05f987, 853399f8-95a7-41f3-80e7-7ed8e3ff1a5e +16NDC 50090-6787, 0168-0056, 0168-0268 +16Application ANDA209106, NDA019141, ANDA075373 +7
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 | 59651-699-14 | Aurobindo PharmaIndia | 10 April 2024 |
| 1 tube in 1 carton / 45 g in 1 tube | 59651-699-46 | Aurobindo PharmaIndia | 10 April 2024 |
| 1 tube in 1 carton / 50 g in 1 tube | 59651-699-50 | Aurobindo PharmaIndia | 10 April 2024 |
| 1 tube in 1 carton / 15 g in 1 tube | 68180-947-01 | LupinIndia | 19 March 2020 |
| 1 tube in 1 carton / 50 g in 1 tube | 68180-947-02 | LupinIndia | 19 March 2020 |
| 1 tube in 1 carton / 15 g in 1 tube | 72578-093-01 | Viona PharmaceuticalsIndia | 20 July 2020 |
| 1 tube in 1 carton / 45 g in 1 tube | 72578-093-06 | Viona PharmaceuticalsIndia | 20 July 2020 |
| 1 tube in 1 carton / 15 g in 1 tube | 70771-1550-1 | Zydus LifesciencesIndia | 20 July 2020 |
| 1 tube in 1 carton / 45 g in 1 tube | 70771-1550-4 | Zydus LifesciencesIndia | 20 July 2020 |
| 1 tube in 1 carton / 15 g in 1 tube | 0472-0381-15 | Actavis Pharma | 1 February 1997 |
| 1 tube in 1 carton / 45 g in 1 tube | 0472-0381-45 | Actavis Pharma | 1 February 1997 |
| 1 tube in 1 carton / 15 g in 1 tube | 0472-0382-15 | Actavis Pharma | 1 September 1995 |
| 1 tube in 1 carton / 45 g in 1 tube | 0472-0382-45 | Actavis Pharma | 1 September 1995 |
| 1 tube in 1 carton / 15 g in 1 tube | 0168-0056-15 | E. Fougera | 4 September 1984 |
| 1 tube in 1 carton / 45 g in 1 tube | 0168-0056-46 | E. Fougera | 4 September 1984 |
| 15 g in 1 tube | 0168-0268-15 | E. Fougera | 22 June 1999 |
| 50 g in 1 tube | 0168-0268-50 | E. Fougera | 22 June 1999 |
| 1 tube in 1 carton / 15 g in 1 tube | 35573-107-15 | Burel Pharmaceuticals | 15 January 2025 |
| 1 tube in 1 carton / 50 g in 1 tube | 35573-107-49 | Burel Pharmaceuticals | 15 January 2025 |
| 1 tube in 1 carton / 15 g in 1 tube | 45802-505-14 | Padagis Israel Pharmaceuticals | 20 May 2022 |
| 1 tube in 1 carton / 45 g in 1 tube | 45802-505-84 | Padagis Israel Pharmaceuticals | 20 May 2022 |
| 1 tube in 1 carton / 15 g in 1 tube | 52817-824-15 | TruPharma | 18 February 2022 |
| 1 tube in 1 carton / 45 g in 1 tube | 52817-824-45 | TruPharma | 18 February 2022 |
| 1 tube in 1 carton / 15 g in 1 tube | 63629-9323-1 | Bryant Ranch Prepack | 7 July 2022 |
| 1 tube in 1 carton / 45 g in 1 tube | 63629-9324-1 | Bryant Ranch Prepack | 7 July 2022 |
| 1 tube in 1 carton / 45 g in 1 tube | 71335-2715-1 | Bryant Ranch Prepack | 28 July 2025 |
| 1 tube in 1 carton / 45 g in 1 tube | 72162-1415-2 | Bryant Ranch Prepack | 12 March 2024 |
| 1 tube in 1 carton / 15 g in 1 tube | 72162-1415-4 | Bryant Ranch Prepack | 12 March 2024 |
| 1 tube in 1 carton / 15 g in 1 tube | 50090-0236-0 | A-S Medication Solutions | 29 June 2016 |
| 1 tube in 1 carton / 50 g in 1 tube | 50090-6787-0 | A-S Medication Solutions | 31 October 2023 |
| 50 g in 1 tube | 50090-7517-0 | A-S Medication Solutions | 11 March 2025 |
| 1 tube in 1 box / 15 g in 1 tube | 66993-897-15 | Prasco Laboratories | 1 June 2021 |
| 1 tube in 1 box / 50 g in 1 tube | 66993-897-49 | Prasco Laboratories | 1 June 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 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
Alternatives
Other makers and brands of Betamethasone dipropionate 0.05% ointment.
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 0.05% ointment for your hospital or patient?
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