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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.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Sun Pharmaceutical Industries, Inc.4gel; tabletGeneric drugs (ANDA)June 26, 2019
Westminster Pharmaceuticals, LLC4tabletGeneric drugs (ANDA)August 21, 2025
Viona Pharmaceuticals Inc3tablet; gelGeneric drugs (ANDA)February 27, 2026
Zydus Lifesciences Limited3tablet; gelGeneric drugs (ANDA)February 27, 2026
Alembic Pharmaceuticals Inc.2gelGeneric drugs (ANDA)July 1, 2026
Alembic Pharmaceuticals Limited2gelGeneric drugs (ANDA)July 1, 2026
Ani Pharmaceuticals, Inc.2tabletGeneric drugs (ANDA)January 15, 2018
Chartwell RX, LLC2tabletGeneric drugs (ANDA)May 10, 2016
Macleods Pharmaceuticals Limited2tabletGeneric drugs (ANDA)July 8, 2026
NorthStar Rx LLC2gelGeneric drugs (ANDA)October 6, 2023
Proficient Rx LP2tabletGeneric drugs (ANDA)August 21, 2025
Rising Pharma Holdings, Inc.2tabletGeneric drugs (ANDA)July 20, 2023
Almirall, LLC1gelNew drug applications (NDA)September 10, 2019
Amneal Pharmaceuticals LLC1gelGeneric drugs (ANDA)October 24, 2023
Aurobindo Pharma Limited1gelGeneric drugs (ANDA)April 4, 2025
AvKARE1tabletGeneric drugs (ANDA)December 10, 2025
AvKARE1tabletGeneric drugs (ANDA)March 6, 2024
Boswell Pharmacy Services LLC D/B/A BPS Wholesale1tabletGeneric drugs (ANDA)August 30, 2024
Cosette Pharmaceuticals, Inc.1gelGeneric drugs (ANDA)May 8, 2023
Coupler LLC1tabletGeneric drugs (ANDA)January 31, 2025
Mayne Pharma1gelGeneric drugs (ANDA)February 11, 2022
Mayne Pharma Inc.1gelGeneric drugs (ANDA)February 14, 2024
Mylan Pharmaceuticals Inc.1gelGeneric drugs (ANDA)May 20, 2022
Pacific Pharma, Inc.1gelAuthorized generics (NDA)October 18, 2017
Torrent Pharmaceuticals Limited1gelGeneric drugs (ANDA)February 10, 2022
TruPharma, LLC1gelGeneric drugs (ANDA)November 20, 2024

Dosage forms

Dosage formProductsShare
Tablet2454.5%
Gel2045.5%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)4295.5%
Authorized generics (NDA)12.3%
New drug applications (NDA)12.3%

Pharmacologic classes

ClassProducts
Sulfone44

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.