Active ingredient
Dexmedetomidine
82 finished FDA listings contain Dexmedetomidine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DEXMEDETOMIDINE, DEXMEDETOMIDINE HYDROCHLORIDE
- Dosage forms
- Film, Injection, Injection, Solution, Injection, Solution, Concentrate
- Routes
- Intravenous, Sublingual
- Manufacturers / labelers
- 27
- Strengths listed
- 100 ug/ml · 120 ug/1 · 180 ug/1 · 200 ug/2ml · 200 ug/50ml · 4 ug/ml · 400 ug/100ml
- Brand names in FDA listings
- Dexmedetomidine Hydrochloride, Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride, Dexmedetomidine Hydrochloride In Sodium Chloride, Dexmedetomidine In Dextrose, Igalmi, Precedex
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 48937
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021038 | HOSPIRA | 1999-12-17 | 14 |
| ANDA 203972 | PH HEALTH | 2014-08-18 | 1 |
| ANDA 202881 | MYLAN INSTITUTIONAL | 2014-08-18 | 1 |
| ANDA 202126 | GLAND | 2015-08-20 | 7 |
| ANDA 201072 | FRESENIUS KABI USA | 2015-09-18 | 2 |
| NDA 206628 | HQ SPCLT PHARMA | 2015-10-21 | 4 |
| ANDA 204023 | ACCORD HLTHCARE | 2016-02-09 | 2 |
| ANDA 205867 | EUGIA PHARMA | 2016-03-17 | 2 |
| ANDA 205046 | HIKMA | 2017-04-26 | 2 |
| ANDA 209065 | HENGRUI PHARMA | 2017-09-19 | 5 |
| ANDA 208532 | BAXTER HLTHCARE CORP | 2018-08-21 | 6 |
| ANDA 204843 | MEITHEAL | 2019-01-18 | 2 |
| ANDA 212791 | WILSHIRE PHARMS INC | 2019-12-04 | 4 |
| ANDA 206407 | HIKMA | 2020-01-30 | 3 |
| ANDA 207551 | AMNEAL PHARMS CO | 2020-05-20 | 2 |
| ANDA 209307 | GLAND | 2020-06-03 | 8 |
| ANDA 212571 | MYLAN LABS LTD | 2020-08-27 | 2 |
| ANDA 208266 | PH HEALTH | 2020-09-15 | 2 |
| ANDA 212857 | TAGI | 2020-11-23 | 3 |
| ANDA 210321 | EUGIA PHARMA | 2020-12-07 | 2 |
| NDA 215390 | BIOXCEL | 2022-04-05 | 2 |
| ANDA 216604 | AMNEAL | 2023-05-15 | 2 |
| ANDA 217308 | MILLA PHARMS | 2023-06-07 | 1 |
| ANDA 218112 | SOMERSET | 2024-09-24 | 2 |
| ANDA 208103 | BAXTER HLTHCARE CORP | 2026-04-15 | 1 |
Official labeling on DailyMed
- DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE INJECTION [SANDOZ INC.] · version 16 · 2026-09-10
- DEXMEDETOMIDINE HYDROCHLORIDE INJECTION [PIRAMAL CRITICAL CARE INC] · version 8 · 2026-08-13
- DEXMEDETOMIDINE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC] · version 7 · 2026-08-07
- DEXMEDETOMIDINE INJECTION, SOLUTION, CONCENTRATE [AVENACY INC.] · version 2 · 2026-08-07
- DEXMEDETOMIDINE INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC] · version 8 · 2026-08-07
- DEXMEDETOMIDINE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] · version 9 · 2026-08-05
- DEXMEDETOMIDINE INJECTION, SOLUTION DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE) INJECTION, SOLUTION [EUGIA US LLC] · version 16 · 2026-07-24
- DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 5 · 2026-07-10
- DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE [BAXTER HEALTHCARE CORPORATION] · version 10 · 2026-07-09
- DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE) INJECTION [AMNEAL PHARMACEUTICALS LLC] · version 15 · 2026-06-29
- DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC] · version 19 · 2026-06-29
- PRECEDEX (DEXMEDETOMIDINE HYDROCHLORIDE) INJECTION, SOLUTION [HOSPIRA, INC.] · version 6 · 2026-06-18
Showing the 12 most recent of 39 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.