Data / Drug companies / Roflumilast
Roflumilast: 17 companies and 33 products in the FDA NDC directory
Roflumilast is listed in the FDA National Drug Code Directory by 17 companies, with 33 products in commercial distribution. 27 of the products (81.8%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; cream; aerosol, foam, and the newest product started marketing on June 24, 2026.
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- Companies listing it
- 17
- Products
- 33
- Generic (ANDA) products
- 27 (81.8%)
- Application numbers
- 12
- Routes
- Oral, Topical
- Brand names
- Zoryve, Daliresp
- openFDA record search
- api.fda.gov
Companies that list roflumilast
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Arcutis Biotherapeutics, Inc. | 4 | cream; aerosol, foam | New drug applications (NDA) | October 4, 2025 |
| Major Pharmaceuticals | 3 | tablet | Generic drugs (ANDA) | October 27, 2025 |
| Amici Pharma, Inc. | 2 | tablet | Generic drugs (ANDA) | February 5, 2026 |
| Ascend Laboratories, LLC | 2 | tablet | Generic drugs (ANDA) | March 14, 2025 |
| AstraZeneca Pharmaceuticals LP | 2 | tablet | New drug applications (NDA) | July 1, 2015 |
| Aurobindo Pharma Limited | 2 | tablet | Generic drugs (ANDA) | January 31, 2025 |
| AvKARE | 2 | tablet | Generic drugs (ANDA) | June 24, 2026 |
| Camber Pharmaceuticals, Inc. | 2 | tablet | Generic drugs (ANDA) | April 18, 2023 |
| Jubilant Cadista Pharmaceuticals Inc. | 2 | tablet | Generic drugs (ANDA) | February 2, 2026 |
| Micro Labs Limited | 2 | tablet | Generic drugs (ANDA) | May 1, 2023 |
| Novadoz Pharmaceuticals LLC | 2 | tablet | Generic drugs (ANDA) | September 7, 2022 |
| Zydus Lifesciences Limited | 2 | tablet | Generic drugs (ANDA) | May 18, 2023 |
| Zydus Pharmaceuticals USA Inc. | 2 | tablet | Generic drugs (ANDA) | May 18, 2023 |
| American Health Packaging | 1 | tablet | Generic drugs (ANDA) | December 7, 2023 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | October 19, 2022 |
| Golden State Medical Supply, Inc. | 1 | tablet | Generic drugs (ANDA) | April 18, 2023 |
| Solco Healthcare US, LLC | 1 | tablet | Generic drugs (ANDA) | May 10, 2022 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet | 29 | 87.9% |
| Cream | 3 | 9.1% |
| Aerosol, foam | 1 | 3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 27 | 81.8% |
| New drug applications (NDA) | 6 | 18.2% |
Pharmacologic classes
| Class | Products |
|---|---|
| Phosphodiesterase 4 Inhibitor | 33 |
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.