Data / Drug companies / Dexmedetomidine hydrochloride
Dexmedetomidine hydrochloride: 21 companies and 53 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Dexmedetomidine hydrochloride is listed in the FDA National Drug Code Directory by 21 companies, with 53 products in commercial distribution. 39 of the products (73.6%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; injection; injection, solution, concentrate, and the newest product started marketing on April 16, 2026.
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- Companies listing it
- 21
- Products
- 53
- Generic (ANDA) products
- 39 (73.6%)
- Application numbers
- 17
- Routes
- Intravenous
- Brand names
- Precedex, Precedex
- openFDA record search
- api.fda.gov
Companies that list dexmedetomidine hydrochloride
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| Hospira, Inc. | 13 | injection, solution; injection, solution, concentrate | New drug applications (NDA) | March 24, 2025 |
| Gland Pharma Limited | 3 | injection | Generic drugs (ANDA) | December 19, 2024 |
| Hikma Pharmaceuticals USA Inc. | 3 | injection, solution | Generic drugs (ANDA) | March 3, 2026 |
| Medical Purchasing Solutions, LLC | 3 | injection, solution | Generic drugs (ANDA) | December 21, 2016 |
| Par Health USA, LLC | 3 | injection, solution; injection, solution, concentrate | Generic drugs (ANDA) | December 4, 2020 |
| Precision Dose, Inc. | 3 | injection, solution | Generic drugs (ANDA) | November 23, 2020 |
| Amneal Pharmaceuticals LLC | 2 | injection, solution | Generic drugs (ANDA) | May 20, 2020 |
| Baxter Healthcare Corporation | 2 | injection | Generic drugs (ANDA) | August 27, 2019 |
| Baxter Healthcare Corporation | 2 | injection | Generic drugs (ANDA) | August 21, 2018 |
| Civica, Inc. | 2 | injection | Generic drugs (ANDA) | August 23, 2021 |
| Dr. Reddy's Laboratories Inc. | 2 | injection, solution | Generic drugs (ANDA) | August 17, 2020 |
| Mylan Institutional LLC | 2 | injection, solution | Generic drugs (ANDA) | November 13, 2020 |
| Piramal Critical Care Inc | 2 | injection | Generic drugs (ANDA) | April 1, 2021 |
| Sagent Pharmaceuticals | 2 | injection; injection, solution | Generic drugs (ANDA) | July 15, 2025 |
| Somerset Therapeutics, LLC | 2 | injection, solution | Generic drugs (ANDA) | September 26, 2024 |
| Wilshire Pharmaceuticals, Inc. | 2 | injection | Generic drugs (ANDA) | January 30, 2025 |
| Baxter Healthcare Corporation | 1 | injection, solution, concentrate | Generic drugs (ANDA) | April 16, 2026 |
| Fresenius Kabi USA, LLC | 1 | injection, solution | Generic drugs (ANDA) | September 18, 2015 |
| Fresenius Kabi USA, LLC | 1 | injection, solution | Generic drugs (ANDA) | September 18, 2015 |
| Henry Schein, Inc. | 1 | injection, solution, concentrate | New drug applications (NDA) | January 13, 2022 |
| Sun Pharmaceutical Industries, Inc. | 1 | injection, solution | Generic drugs (ANDA) | April 8, 2015 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 35 | 66% |
| Injection | 14 | 26.4% |
| Injection, solution, concentrate | 4 | 7.5% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 39 | 73.6% |
| New drug applications (NDA) | 14 | 26.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Central alpha-2 Adrenergic Agonist | 53 |
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.