Quick answers
- What is Dexmedetomidine used for?
- The FDA-approved label (Precedex, Hospira, Inc., June 17, 2026) says: “PRECEDEX is a alpha 2 -adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer PRECEDEX by continuous infusion not to exceed 24 hours. • Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Dexmedetomidine have a boxed warning?
- No. None of the 36 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Dexmedetomidine?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated October 27, 2026). Ask your pharmacist about alternatives.
- Has Dexmedetomidine been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started August 6, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Dexmedetomidine?
- 27 companies list prescription products of Dexmedetomidine in the FDA NDC Directory, including Hospira, Inc., Baxter Healthcare Company and Medical Purchasing Solutions, LLC.
What Dexmedetomidine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PRECEDEX is a alpha 2 -adrenergic receptor agonist indicated for: • Sedation of initially intubated and mechanically ventilated adult patients during treatment in an intensive care setting. Administer PRECEDEX by continuous infusion not to exceed 24 hours. • Sedation of non-intubated adult patients prior to and/or during surgical and other procedures. …
— FDA label: Precedex, Hospira, Inc., effective June 17, 2026. Read the full label on DailyMed →
The FDA has 36 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 36 FDA labels for this medicine have a boxed warning.
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Hospira, Inc.13 products
- Baxter Healthcare Company6 products
- Medical Purchasing Solutions, LLC5 products
- Hikma Pharmaceuticals USA Inc.4 products
- WG Critical Care, LLC4 products
- Piramal Critical Care Inc4 products
- Gland Pharma Limited4 products
- Amneal Pharmaceuticals LLC4 products
- ProPharma Distribution3 products
- Precision Dose, Inc.3 products
- Eugia US LLC3 products
- Par Health USA, LLC3 products
- Mylan Institutional LLC3 products
- Sandoz Inc3 products
- Fresenius Kabi USA, LLC2 products
- Dr. Reddy's Laboratories Inc.2 products
- Wilshire Pharmaceuticals, Inc.2 products
- Somerset Therapeutics, LLC2 products
- Civica, Inc.2 products
- Sagent Pharmaceuticals2 products
- BioXcel Therapeutics, Inc.2 products
- Meitheal Pharmaceuticals Inc.1 product
- Sun Pharmaceuticals Industries, Inc.1 product
- Avenacy Inc.1 product
- Accord Healthcare Inc.1 product
- Henry Schein, Inc.1 product
- Baxter Healthcare Corporation1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021038 PRECEDEX | Hospira | December 17, 1999 | 20, latest May 1, 2026 2026: Labeling · 2024: UNKNOWN · 2022: Efficacy |
| NDA206628 DEXMEDETOMIDINE HYDROCHLORIDE | Hq Spclt Pharma | October 21, 2015 | 5, latest May 1, 2026 2026: Labeling · 2024: Labeling · 2021: Manufacturing (CMC) |
| NDA215390 IGALMI | Bioxcel | April 5, 2022 | 2, latest November 19, 2025 2025: Efficacy · 2022: Labeling |
Generic approvals (22)
- ANDA202881Mylan Institutional · August 18, 2014
- ANDA203972Ph Health · August 18, 2014
- ANDA202126Gland · August 20, 2015
- ANDA201072Fresenius Kabi USA · September 18, 2015
- ANDA204023Accord Hlthcare · February 9, 2016
- ANDA205867Eugia Pharma · March 17, 2016
- ANDA205046Hikma · April 26, 2017
- ANDA209065Hengrui Pharma · September 19, 2017
- ANDA208532Baxter Hlthcare Corp · August 21, 2018
- ANDA204843Meitheal · January 18, 2019
- ANDA212791Wilshire Pharms Inc · December 4, 2019
- ANDA206407Hikma · January 30, 2020
- ANDA207551Amneal Pharms Co · May 20, 2020
- ANDA209307Gland · June 3, 2020
- ANDA212571Mylan Labs Ltd · August 27, 2020
- ANDA208266Ph Health · September 15, 2020
- ANDA212857Tagi · November 23, 2020
- ANDA210321Eugia Pharma · December 7, 2020
- ANDA216604Amneal · May 15, 2023
- ANDA217308Milla Pharms · June 7, 2023
- ANDA218112Somerset · September 24, 2024
- ANDA208103Baxter Hlthcare Corp · April 15, 2026
Shortage status
Current shortage · updated October 27, 2026 · first posted April 10, 2020
| Product | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 70069-759-04) |
|---|---|
| Availability | Available |
| Company | Somerset Therapeutics, LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 6, 2026 · Class II · Ongoing · D-0810-2026
CGMP Deviations
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12. — Baxter Healthcare Corporation
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Precedex, Hospira, Inc., effective June 17, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →