Dapsone 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 dapsone gel at controlled room temperature…
Key facts
- Active ingredient (INN)
- Dapsone
- Brand
- Sold under the generic name
- Strength
- 5%
- Dosage form
- Gel
- Route
- Topical
- Packs
- 1 tube and 23 more
- Manufacturers
- Alembic PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaAurobindo PharmaIndiaAmneal PharmaceuticalsPacific PharmaCosette PharmaceuticalsEncube EthicalsNorthStar RxTruPharmaMayne Pharma
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store dapsone gel at controlled room temperature, 20°-25°C (68°-77°F), excursions permitted to 15°-30ºC (59°-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
- 16 October 2017
- Identifiers
- RxCUI 607295DailyMed set ID 8dbe1a41-6d9d-414f-aa9c-09bd95857e2a, 7249f655-1d8e-482a-889a-1e7e1a19500c, 0f1301f6-884d-4fc7-a5b2-421b2375b985 +8NDC 60758-670, 62332-551, 46708-551 +8Application NDA021794, ANDA213414, ANDA209506 +5
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 / 30 g in 1 tube | 46708-551-30 | Alembic PharmaceuticalsIndia | 1 July 2026 |
| 1 tube in 1 carton / 60 g in 1 tube | 46708-551-60 | Alembic PharmaceuticalsIndia | 1 July 2026 |
| 1 tube in 1 carton / 90 g in 1 tube | 46708-551-90 | Alembic PharmaceuticalsIndia | 1 July 2026 |
| 1 tube in 1 carton / 30 g in 1 tube | 62332-551-30 | Alembic PharmaceuticalsIndia | 1 July 2026 |
| 1 tube in 1 carton / 60 g in 1 tube | 62332-551-60 | Alembic PharmaceuticalsIndia | 1 July 2026 |
| 1 tube in 1 carton / 90 g in 1 tube | 62332-551-90 | Alembic PharmaceuticalsIndia | 1 July 2026 |
| 1 tube in 1 carton / 60 g in 1 tube | 59651-666-60 | Aurobindo PharmaIndia | 4 April 2025 |
| 1 tube in 1 carton / 90 g in 1 tube | 59651-666-90 | Aurobindo PharmaIndia | 4 April 2025 |
| 1 tube in 1 carton / 30 g in 1 tube | 51672-1387-2 | Sun Pharmaceutical IndustriesIndia | 16 October 2017 |
| 1 tube in 1 carton / 60 g in 1 tube | 51672-1387-3 | Sun Pharmaceutical IndustriesIndia | 16 October 2017 |
| 1 tube in 1 carton / 90 g in 1 tube | 51672-1387-8 | Sun Pharmaceutical IndustriesIndia | 16 October 2017 |
| 1 tube in 1 carton / 30 g in 1 tube | 65162-339-63 | Amneal Pharmaceuticals | 24 October 2023 |
| 1 tube in 1 carton / 60 g in 1 tube | 65162-339-85 | Amneal Pharmaceuticals | 24 October 2023 |
| 1 tube in 1 carton / 90 g in 1 tube | 65162-339-91 | Amneal Pharmaceuticals | 24 October 2023 |
| 1 tube in 1 carton / 90 g in 1 tube | 0713-0886-18 | Cosette Pharmaceuticals | 8 May 2023 |
| 1 tube in 1 carton / 60 g in 1 tube | 0713-0886-60 | Cosette Pharmaceuticals | 8 May 2023 |
| 1 tube in 1 carton / 60 g in 1 tube | 21922-018-07 | Encube Ethicals | 16 October 2023 |
| 1 tube in 1 carton / 90 g in 1 tube | 21922-018-08 | Encube Ethicals | 16 October 2023 |
| 1 tube in 1 carton / 60 g in 1 tube | 51862-123-60 | Mayne Pharma | 14 February 2024 |
| 1 tube in 1 carton / 30 g in 1 tube | 60758-670-30 | Pacific Pharma | 18 October 2017 |
| 1 tube in 1 carton / 60 g in 1 tube | 60758-670-60 | Pacific Pharma | 18 October 2017 |
| 1 tube in 1 carton / 90 g in 1 tube | 60758-670-90 | Pacific Pharma | 18 October 2017 |
| 1 tube in 1 carton / 60 g in 1 tube | 52817-831-60 | Trupharma | 1 March 2024 |
| 1 tube in 1 carton / 90 g in 1 tube | 52817-831-90 | Trupharma | 1 March 2024 |
| 1 tube in 1 carton / 60 g in 1 tube | 16714-956-01 | Northstar RX | 25 April 2019 |
| 1 tube in 1 carton / 90 g in 1 tube | 16714-956-02 | Northstar RX | 25 April 2019 |
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
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 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.