Data / Drug companies / Dapsone
Dapsone: 26 companies and 44 products in the FDA NDC directory
Dapsone is listed in the FDA National Drug Code Directory by 26 companies, with 44 products in commercial distribution. 42 of the products (95.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; gel, and the newest product started marketing on July 8, 2026.
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- Companies listing it
- 26
- Products
- 44
- Generic (ANDA) products
- 42 (95.5%)
- Application numbers
- 22
- Routes
- Oral, Topical
- Brand names
- Aczone
- openFDA record search
- api.fda.gov
Companies that list dapsone
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. | 4 | gel; tablet | Generic drugs (ANDA) | June 26, 2019 |
| Westminster Pharmaceuticals, LLC | 4 | tablet | Generic drugs (ANDA) | August 21, 2025 |
| Viona Pharmaceuticals Inc | 3 | tablet; gel | Generic drugs (ANDA) | February 27, 2026 |
| Zydus Lifesciences Limited | 3 | tablet; gel | Generic drugs (ANDA) | February 27, 2026 |
| Alembic Pharmaceuticals Inc. | 2 | gel | Generic drugs (ANDA) | July 1, 2026 |
| Alembic Pharmaceuticals Limited | 2 | gel | Generic drugs (ANDA) | July 1, 2026 |
| Ani Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | January 15, 2018 |
| Chartwell RX, LLC | 2 | tablet | Generic drugs (ANDA) | May 10, 2016 |
| Macleods Pharmaceuticals Limited | 2 | tablet | Generic drugs (ANDA) | July 8, 2026 |
| NorthStar Rx LLC | 2 | gel | Generic drugs (ANDA) | October 6, 2023 |
| Proficient Rx LP | 2 | tablet | Generic drugs (ANDA) | August 21, 2025 |
| Rising Pharma Holdings, Inc. | 2 | tablet | Generic drugs (ANDA) | July 20, 2023 |
| Almirall, LLC | 1 | gel | New drug applications (NDA) | September 10, 2019 |
| Amneal Pharmaceuticals LLC | 1 | gel | Generic drugs (ANDA) | October 24, 2023 |
| Aurobindo Pharma Limited | 1 | gel | Generic drugs (ANDA) | April 4, 2025 |
| AvKARE | 1 | tablet | Generic drugs (ANDA) | December 10, 2025 |
| AvKARE | 1 | tablet | Generic drugs (ANDA) | March 6, 2024 |
| Boswell Pharmacy Services LLC D/B/A BPS Wholesale | 1 | tablet | Generic drugs (ANDA) | August 30, 2024 |
| Cosette Pharmaceuticals, Inc. | 1 | gel | Generic drugs (ANDA) | May 8, 2023 |
| Coupler LLC | 1 | tablet | Generic drugs (ANDA) | January 31, 2025 |
| Mayne Pharma | 1 | gel | Generic drugs (ANDA) | February 11, 2022 |
| Mayne Pharma Inc. | 1 | gel | Generic drugs (ANDA) | February 14, 2024 |
| Mylan Pharmaceuticals Inc. | 1 | gel | Generic drugs (ANDA) | May 20, 2022 |
| Pacific Pharma, Inc. | 1 | gel | Authorized generics (NDA) | October 18, 2017 |
| Torrent Pharmaceuticals Limited | 1 | gel | Generic drugs (ANDA) | February 10, 2022 |
| TruPharma, LLC | 1 | gel | Generic drugs (ANDA) | November 20, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 24 | 54.5% |
| Gel | 20 | 45.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 42 | 95.5% |
| Authorized generics (NDA) | 1 | 2.3% |
| New drug applications (NDA) | 1 | 2.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Sulfone | 44 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.