Data / Drug companies / Ramelteon
Ramelteon: 29 companies and 41 products in the FDA NDC directory
Ramelteon is listed in the FDA National Drug Code Directory by 29 companies, with 41 products in commercial distribution. 40 of the products (97.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet, film coated; tablet, and the newest product started marketing on July 27, 2026.
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- Companies listing it
- 29
- Products
- 41
- Generic (ANDA) products
- 40 (97.6%)
- Application numbers
- 11
- Routes
- Oral
- Brand names
- Rozerem
- openFDA record search
- api.fda.gov
Companies that list ramelteon
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Bryant Ranch Prepack | 5 | tablet, film coated; tablet | Generic drugs (ANDA) | July 10, 2023 |
| Bryant Ranch Prepack | 4 | tablet, film coated; tablet | Generic drugs (ANDA) | April 21, 2026 |
| Advanced Rx of Tennessee, LLC | 3 | tablet, film coated; tablet | Generic drugs (ANDA) | July 27, 2026 |
| Direct_Rx | 3 | tablet, film coated; tablet | Generic drugs (ANDA) | June 1, 2023 |
| Asclemed USA, Inc. | 2 | tablet, film coated; tablet | Generic drugs (ANDA) | July 10, 2023 |
| Actavis Pharma, Inc. | 1 | tablet | Generic drugs (ANDA) | July 22, 2019 |
| American Health Packaging | 1 | tablet | Generic drugs (ANDA) | February 20, 2023 |
| Asclemed USA Inc. | 1 | tablet | Generic drugs (ANDA) | May 1, 2023 |
| Aurobindo Pharma Limited | 1 | tablet, film coated | Generic drugs (ANDA) | July 10, 2023 |
| AvKARE | 1 | tablet | Generic drugs (ANDA) | December 21, 2020 |
| AvPAK | 1 | tablet | Generic drugs (ANDA) | May 20, 2026 |
| Bryant Ranch Prepack | 1 | tablet | Generic drugs (ANDA) | October 1, 2020 |
| Golden State Medical Supply, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | November 25, 2022 |
| Granules Pharmaceuticals Inc. | 1 | tablet | Generic drugs (ANDA) | October 1, 2020 |
| I3 Pharmaceuticals, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | April 30, 2020 |
| Kanchan Healthcare Inc | 1 | tablet, film coated | Generic drugs (ANDA) | April 21, 2026 |
| Major Pharmaceuticals | 1 | tablet | Generic drugs (ANDA) | January 10, 2025 |
| Marlex Pharmaceuticals, Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | July 1, 2026 |
| Micro Labs Limited | 1 | tablet | Generic drugs (ANDA) | May 1, 2023 |
| Proficient Rx LP | 1 | tablet, film coated | Generic drugs (ANDA) | June 30, 2020 |
| Proficient Rx LP | 1 | tablet | Generic drugs (ANDA) | October 1, 2020 |
| Remedyrepack Inc. | 1 | tablet, film coated | Generic drugs (ANDA) | January 20, 2025 |
| Sportpharm LLC | 1 | tablet | Generic drugs (ANDA) | May 1, 2023 |
| Takeda Pharmaceuticals America, Inc. | 1 | tablet, film coated | New drug applications (NDA) | July 22, 2005 |
| TruPharma, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | June 30, 2020 |
| Upsher-Smith Laboratories, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | October 26, 2020 |
| Xiromed, LLC | 1 | tablet, film coated | Generic drugs (ANDA) | November 25, 2022 |
| Zydus Lifesciences Limited | 1 | tablet | Generic drugs (ANDA) | July 23, 2019 |
| Zydus Pharmaceuticals USA Inc. | 1 | tablet | Generic drugs (ANDA) | July 23, 2019 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 22 | 53.7% |
| Tablet | 19 | 46.3% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 40 | 97.6% |
| New drug applications (NDA) | 1 | 2.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Melatonin Receptor Agonist | 41 |
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.