Data / Drug companies / Dexmedetomidine
Dexmedetomidine: 11 companies and 17 products in the FDA NDC directory
Dexmedetomidine is listed in the FDA National Drug Code Directory by 11 companies, with 17 products in commercial distribution. 11 of the products (64.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; injection, solution, concentrate; film, and the newest product started marketing on March 15, 2024.
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- Companies listing it
- 11
- Products
- 17
- Generic (ANDA) products
- 11 (64.7%)
- Application numbers
- 8
- Routes
- Intravenous, Sublingual
- Brand names
- Igalmi
- openFDA record search
- api.fda.gov
Companies that list dexmedetomidine
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| WG Critical Care, LLC | 4 | injection, solution, concentrate; injection | New drug applications (NDA) | April 19, 2016 |
| BioXcel Therapeutics, Inc. | 2 | film | New drug applications (NDA) | July 1, 2022 |
| Piramal Critical Care Inc | 2 | injection, solution | Generic drugs (ANDA) | May 1, 2021 |
| ProPharma Distribution | 2 | injection, solution | Generic drugs (ANDA) | January 19, 2021 |
| Accord Healthcare Inc. | 1 | injection, solution | Generic drugs (ANDA) | December 21, 2016 |
| Avenacy, LLC | 1 | injection, solution, concentrate | Generic drugs (ANDA) | March 15, 2024 |
| Eugia US LLC | 1 | injection, solution | Generic drugs (ANDA) | March 17, 2016 |
| Gland Pharma Limited | 1 | injection, solution | Generic drugs (ANDA) | June 28, 2021 |
| Medical Purchasing Solutions, LLC | 1 | injection, solution | Generic drugs (ANDA) | January 19, 2021 |
| Meitheal Pharmaceuticals Inc. | 1 | injection, solution | Generic drugs (ANDA) | January 18, 2019 |
| Mylan Institutional LLC | 1 | injection, solution, concentrate | Generic drugs (ANDA) | August 18, 2014 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 9 | 52.9% |
| Injection, solution, concentrate | 4 | 23.5% |
| Film | 2 | 11.8% |
| Injection | 2 | 11.8% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 11 | 64.7% |
| New drug applications (NDA) | 6 | 35.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Central alpha-2 Adrenergic Agonist | 17 |
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.