Dapsone 100 mg tablet is a generic prescription medicine for oral use, made by 13 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 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…
Key facts
- Active ingredient (INN)
- Dapsone
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 30 tablets, 100 tablets, 1000 tablets and 28 more
- Manufacturers
- Macleods PharmaceuticalsIndiaViona PharmaceuticalsIndiaZydus LifesciencesIndiaSun Pharmaceutical IndustriesIndiaProficient RxWestminster PharmaceuticalsANI PharmaceuticalsEverest Life SciencesRising Pharma HoldingsSolis Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
- 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
- 9 May 2016
- Identifiers
- RxCUI 197557, 197558DailyMed set ID 1d6bc112-ba2f-40ab-975d-9cfbc853cd11, 347c753b-8daa-40f8-9391-0339c9d6679c, cb312185-b9f1-4fa4-9481-bcf5d9bb3edf +11NDC 70771-1980, 82804-938, 51672-4198 +11Application ANDA220103, ANDA086842, ANDA209430 +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 |
|---|---|---|---|
| 30 tablet in 1 bottle | 33342-535-07 | Macleods PharmaceuticalsIndia | 8 July 2026 |
| 100 tablet in 1 bottle | 33342-535-11 | Macleods PharmaceuticalsIndia | 8 July 2026 |
| 30 tablet in 1 bottle | 51672-4198-6 | Sun Pharmaceutical IndustriesIndia | 1 March 2019 |
| 100 tablet in 1 bottle | 72578-178-01 | Viona PharmaceuticalsIndia | 27 February 2026 |
| 30 tablet in 1 bottle | 72578-178-06 | Viona PharmaceuticalsIndia | 27 February 2026 |
| 100 tablet in 1 bottle | 70771-1980-1 | Zydus LifesciencesIndia | 27 February 2026 |
| 30 tablet in 1 bottle | 70771-1980-3 | Zydus LifesciencesIndia | 27 February 2026 |
| 30 tablet in 1 bottle | 70954-136-10 | ANI Pharmaceuticals | 15 January 2018 |
| 100 tablet in 1 bottle | 70954-136-20 | ANI Pharmaceuticals | 15 January 2018 |
| 30 tablet in 1 blister pack | 83209-566-30 | BPS Wholesale | 30 August 2024 |
| 30 tablet in 1 bottle | 62135-966-30 | Chartwell RX | 8 April 2025 |
| 100 tablet in 1 bottle | 83098-101-01 | Everest Life Sciences | 1 September 2024 |
| 30 tablet in 1 bottle | 83098-101-03 | Everest Life Sciences | 1 September 2024 |
| 100 tablet in 1 bottle | 64980-566-01 | Rising Pharma Holdings | 11 December 2022 |
| 30 tablet in 1 bottle | 64980-566-03 | Rising Pharma Holdings | 12 July 2023 |
| 30 tablet in 1 bottle | 85185-105-01 | Solis Pharmaceuticals | 9 May 2016 |
| 100 tablet in 1 bottle | 85185-105-02 | Solis Pharmaceuticals | 9 May 2016 |
| 100 tablet in 1 bottle | 69367-379-01 | Westminster Pharmaceuticals | 16 January 2024 |
| 30 tablet in 1 bottle | 69367-379-30 | Westminster Pharmaceuticals | 16 January 2024 |
| 100 tablet in 1 bottle | 69367-410-01 | Westminster Pharmaceuticals | 21 August 2025 |
| 30 tablet in 1 bottle | 69367-410-30 | Westminster Pharmaceuticals | 21 August 2025 |
| 30 tablet in 1 blister pack | 67046-1477-3 | Coupler | 31 January 2025 |
| 100 tablet in 1 bottle | 82804-938-00 | Proficient Rx | 23 October 2026 |
| 1000 tablet in 1 bottle | 82804-938-11 | Proficient Rx | 23 October 2026 |
| 30 tablet in 1 bottle | 82804-938-30 | Proficient Rx | 23 October 2026 |
| 500 tablet in 1 bottle | 82804-938-55 | Proficient Rx | 23 October 2026 |
| 60 tablet in 1 bottle | 82804-938-60 | Proficient Rx | 23 October 2026 |
| 240 tablet in 1 bottle | 82804-938-64 | Proficient Rx | 23 October 2026 |
| 120 tablet in 1 bottle | 82804-938-72 | Proficient Rx | 23 October 2026 |
| 180 tablet in 1 bottle | 82804-938-78 | Proficient Rx | 23 October 2026 |
| 90 tablet in 1 bottle | 82804-938-90 | Proficient Rx | 23 October 2026 |
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 100 mg tablet 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.