Quick answers
- What is Precedex?
- Precedex is a brand name of Dexmedetomidine, a prescription medicine. The FDA NDC Directory lists 14 Precedex products in 2 strengths and forms.
- Who makes Precedex?
- Hospira holds the FDA application for Precedex (NDA021038, approved December 17, 1999). 1 other company (repackagers or distributors) also list Precedex products.
- Is there a generic or store brand of Precedex?
- Yes. The FDA NDC Directory lists 21 other products with the same active ingredients, strength and form as a Precedex product, 19 of them generic. Ask your pharmacist whether one is right for you.
- Has Precedex been recalled?
- No recall linked to Precedex products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Precedex is
Each Precedex product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Dexmedetomidine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| dexmedetomidine hydrochloride 100 ug/mL injection, solution, concentrate (intravenous) | Precedex | 6 products, 5 companies | DailyMed |
| dexmedetomidine hydrochloride 4 ug/mL injection, solution (intravenous) | Precedex | 15 products, 7 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Dexmedetomidine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA021038 | Hospira | December 17, 1999 | 14 |
Companies that list Precedex
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Precedex products.
- Hospira, Inc.13 products
- Henry Schein, Inc.1 product
Recalls
No recall linked to Precedex products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.