Drug
Who makes dapsone?
26 companies list dapsone as a human prescription drug, including under the names Aczone. Forms: gel; tablet. Routes: oral, topical.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing dapsone
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Sun Pharmaceutical Industries LimitedIndia | gel; tablet | ANDAANDA209430, ANDA209506, ANDA210191 | 4 | 13 |
| Alembic Pharmaceuticals LimitedIndia | gel | ANDAANDA213414, ANDA215718 | 4 | 7 |
| Westminster Pharmaceuticals, LLC | tablet | ANDAANDA086841, ANDA086842 | 4 | 0 |
| Zydus Lifesciences LimitedIndia | gel; tablet | ANDAANDA214019, ANDA220103 | 3 | 12 |
| Viona Pharmaceuticals Inc. | gel; tablet | ANDAANDA214019, ANDA220103 | 3 | 0 |
| Macleods Pharmaceuticals LimitedIndia | tablet | ANDAANDA218335 | 2 | 5 |
| ANI Pharmaceuticals, Inc.United States | tablet | ANDAANDA206505 | 2 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA086841, ANDA086842 | 2 | 1 |
| Rising Pharma Holdings, Inc.United States | tablet | ANDAANDA207165 | 2 | 1 |
| AvKARE | tablet | ANDAANDA086841 | 2 | 0 |
| Chartwell RX, LLC. | tablet | ANDAANDA204074 | 2 | 0 |
| Northstar Rx, LLC, | gel | ANDAANDA209506, ANDA210191 | 2 | 0 |
| Allergan, Inc.United States | gel | NDANDA021794 | 1 | 7 |
| Aurobindo Pharma LimitedIndia | gel | ANDAANDA218457 | 1 | 6 |
| Torrent Pharma, Inc.India | gel | ANDAANDA214722 | 1 | 5 |
| Pacific Medical Industries LtdUnited States | gel | NDA AUTHORIZED GENERICNDA021794 | 1 | 4 |
| Amneal Ireland LimitedIreland | gel | ANDAANDA209890 | 1 | 1 |
| Boswell Pharmacy Services LLCUnited States | tablet | ANDAANDA207165 | 1 | 1 |
| Coupler LLCUnited States | tablet | ANDAANDA207165 | 1 | 1 |
| Golden State Medical Supply Inc.United States | tablet | ANDAANDA203887 | 1 | 1 |
| Mayne Pharma International Pty Ltd.Australia | gel | ANDAANDA212383 | 1 | 1 |
| Almirall, LLC | gel | NDANDA207154 | 1 | 0 |
| Cosette Pharmaceuticals, Inc. | gel | ANDAANDA210178 | 1 | 0 |
| Mayne Pharma Commercial LLC. | gel | ANDAANDA214722 | 1 | 0 |
| Mylan Pharmaceuticals, Inc. | gel | ANDAANDA213847 | 1 | 0 |
| TruPharma LLC. | gel | ANDAANDA213636 | 1 | 0 |
Bulk ingredient listings
- Professional Compounding Centers of America dba PCCAUnited States · 3 NDC
- AX Pharmaceutical CorpCanada · 1 NDC
- Atul Ltd.India · 1 NDC
- Cohance Lifesciences LimitedIndia · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Dipharma Francis SrlItaly · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- Haleos Labs LimitedIndia · 1 NDC
- LETCO MEDICAL, LLCUnited States · 1 NDC
- Medilux Laboratories PVT LtdIndia · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- STHREE CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
- Sai Life Sciences LimitedIndia · 1 NDC
Orange Book patents
1 unexpired patent lists dapsone as the active ingredient, expiring between Nov 2033 and Nov 2033. Application holder: ALMIRALL LLC.
Enquiry
Common questions
- Who makes dapsone?
- 26 companies list dapsone as a human prescription drug in the openFDA NDC Directory, led by Sun Pharmaceutical Industries Limited, Alembic Pharmaceuticals Limited, Westminster Pharmaceuticals, LLC, Zydus Lifesciences Limited, Viona Pharmaceuticals Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Aczone?
- 23 companies list dapsone under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies dapsone active ingredient?
- 13 companies list dapsone as a bulk ingredient, including Professional Compounding Centers of America dba PCCA, AX Pharmaceutical Corp, Atul Ltd., Cohance Lifesciences Limited.