Data / Drug companies / Isotretinoin
Isotretinoin: 16 companies and 97 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Isotretinoin is listed in the FDA National Drug Code Directory by 16 companies, with 97 products in commercial distribution. 81 of the products (83.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are capsule; capsule, liquid filled; capsule, gelatin coated, and the newest product started marketing on September 10, 2026.
The request: Get every company that lists isotretinoin in the FDA NDC directory, with headquarters, website and number of employees. $10 of work on sign-up, no card.
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- Companies listing it
- 16
- Products
- 97
- Generic (ANDA) products
- 81 (83.5%)
- Application numbers
- 16
- Routes
- Oral
- Brand names
- Zenatane, Absorica, Absorica LD, Claravis, Accutane, Amnesteem
- openFDA record search
- api.fda.gov
Companies that list isotretinoin
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Amneal Pharmaceuticals NY LLC | 10 | capsule; capsule, liquid filled | Generic drugs (ANDA) | October 10, 2025 |
| Sun Pharmaceutical Industries, Inc. | 10 | capsule | New drug applications (NDA) | November 20, 2019 |
| Zydus Lifesciences Limited | 10 | capsule | Generic drugs (ANDA) | June 9, 2025 |
| Zydus Pharmaceuticals USA Inc. | 10 | capsule | Generic drugs (ANDA) | June 9, 2025 |
| Mayne Pharma | 8 | capsule, liquid filled | Generic drugs (ANDA) | September 21, 2021 |
| Actavis Pharma, Inc. | 6 | capsule | Generic drugs (ANDA) | April 29, 2021 |
| Aurobindo Pharma Limited | 6 | capsule | Generic drugs (ANDA) | January 29, 2024 |
| Sun Pharmaceutical Industries, Inc. | 6 | capsule | Authorized generics (NDA) | December 29, 2020 |
| BluePoint Laboratories | 4 | capsule, gelatin coated | Generic drugs (ANDA) | December 30, 2025 |
| Dr. Reddy's Laboratories Limited | 4 | capsule, gelatin coated | Generic drugs (ANDA) | March 9, 2015 |
| JG Pharma Inc. | 4 | capsule, gelatin coated | Generic drugs (ANDA) | August 1, 2022 |
| Mylan Pharmaceuticals Inc. | 4 | capsule | Generic drugs (ANDA) | April 10, 2025 |
| Teva Pharmaceuticals USA, Inc. | 4 | capsule, liquid filled | Generic drugs (ANDA) | May 18, 2006 |
| Upsher-Smith Laboratories, LLC | 4 | capsule, liquid filled | Generic drugs (ANDA) | September 21, 2021 |
| Upsher-Smith Laboratories, LLC | 4 | capsule, liquid filled | Generic drugs (ANDA) | August 26, 2015 |
| Aurobindo Pharma Limited | 3 | capsule | Generic drugs (ANDA) | September 10, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Capsule | 61 | 62.9% |
| Capsule, liquid filled | 24 | 24.7% |
| Capsule, gelatin coated | 12 | 12.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 81 | 83.5% |
| New drug applications (NDA) | 10 | 10.3% |
| Authorized generics (NDA) | 6 | 6.2% |
Pharmacologic classes
| Class | Products |
|---|---|
| Retinoid | 97 |
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.