Dapsone 7.5% gel 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
Protect from freezing. Store at 20°C to 25°C (68°F to 77°F), excursions…
Key facts
- Active ingredient (INN)
- Dapsone
- Brand
- Sold under the generic name
- Strength
- 7.5%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 bottle, 1 tube and 24 more
- Manufacturers
- Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaTorrent PharmaceuticalsIndiaAmneal Pharmaceuticals NYMayne Pharma CommercialMylan PharmaceuticalsNorthStar RxTruPharma
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30ºC (59°F to 86ºF).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- D10AX05 Dapsone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 26 June 2019
- Identifiers
- RxCUI 1741905DailyMed set ID 30867c69-cf3c-4360-8e56-db96e0b0c3ab, cbf9e81e-00ef-4218-975e-6a1610b7f1dd, 32fcb7e0-5a6d-4d95-b81c-148012a54112 +8NDC 72578-094, 68308-342, 51672-1388 +8Application ANDA214019, ANDA214722, ANDA210191 +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, pump in 1 carton / 30 g in 1 bottle, pump | 46708-663-30 | Alembic PharmaceuticalsIndia | 30 October 2023 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 46708-663-60 | Alembic PharmaceuticalsIndia | 30 October 2023 |
| 1 bottle, pump in 1 carton / 90 g in 1 bottle, pump | 46708-663-90 | Alembic PharmaceuticalsIndia | 30 October 2023 |
| 1 bottle, pump in 1 carton / 30 g in 1 bottle, pump | 62332-663-30 | Alembic PharmaceuticalsIndia | 30 October 2023 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 62332-663-60 | Alembic PharmaceuticalsIndia | 30 October 2023 |
| 1 bottle, pump in 1 carton / 90 g in 1 bottle, pump | 62332-663-90 | Alembic PharmaceuticalsIndia | 30 October 2023 |
| 1 bottle, pump in 1 carton / 30 g in 1 bottle, pump | 51672-1388-2 | Sun Pharmaceutical IndustriesIndia | 26 June 2019 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 51672-1388-3 | Sun Pharmaceutical IndustriesIndia | 26 June 2019 |
| 1 bottle, pump in 1 carton / 90 g in 1 bottle, pump | 51672-1388-8 | Sun Pharmaceutical IndustriesIndia | 26 June 2019 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 13668-605-05 | Torrent PharmaceuticalsIndia | 10 February 2022 |
| 1 bottle, pump in 1 carton / 90 g in 1 bottle, pump | 13668-605-08 | Torrent PharmaceuticalsIndia | 10 February 2022 |
| 1 bottle, pump in 1 carton / 30 g in 1 bottle, pump | 72578-094-01 | Viona PharmaceuticalsIndia | 10 May 2024 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 72578-094-02 | Viona PharmaceuticalsIndia | 10 May 2024 |
| 1 bottle, pump in 1 carton / 90 g in 1 bottle, pump | 72578-094-03 | Viona PharmaceuticalsIndia | 10 May 2024 |
| 1 bottle, pump in 1 carton / 30 g in 1 bottle, pump | 70771-1538-2 | Zydus LifesciencesIndia | 10 May 2024 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 70771-1538-3 | Zydus LifesciencesIndia | 10 May 2024 |
| 1 bottle, pump in 1 carton / 90 g in 1 bottle, pump | 70771-1538-8 | Zydus LifesciencesIndia | 10 May 2024 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 69238-1627-6 | Amneal Pharmaceuticals NY | 2 June 2023 |
| 1 bottle, pump in 1 carton / 90 g in 1 bottle, pump | 69238-1627-9 | Amneal Pharmaceuticals NY | 2 June 2023 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 68308-342-60 | Mayne Pharma Commercial | 11 February 2022 |
| 1 bottle, pump in 1 carton / 90 g in 1 bottle, pump | 68308-342-90 | Mayne Pharma Commercial | 11 February 2022 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 0378-4830-60 | Mylan Pharmaceuticals | 20 May 2022 |
| 1 bottle, pump in 1 carton / 90 g in 1 bottle, pump | 0378-4830-90 | Mylan Pharmaceuticals | 20 May 2022 |
| 1 tube in 1 carton / 60 g in 1 tube | 52817-832-60 | Trupharma | 20 November 2024 |
| 1 tube in 1 carton / 90 g in 1 tube | 52817-832-90 | Trupharma | 20 November 2024 |
| 1 bottle, pump in 1 carton / 60 g in 1 bottle, pump | 16714-975-01 | Northstar RX | 6 October 2023 |
| 1 bottle, pump in 1 carton / 90 g in 1 bottle, pump | 16714-975-02 | Northstar RX | 6 October 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 7 July 2005 | 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 Dapsone 7.5% gel.
Other strengths and forms of Dapsone
Clinical summary
Dapsone is a sulfone indicated for the topical treatment of acne vulgaris. It is available as tablets and gel for oral and topical use. MedsAcross supplies Dapsone 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 DapsoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DAPSONE prescribing information (Pacific Pharma) · U.S. National Library of Medicine, DailyMed
Need Dapsone 7.5% gel 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.