Quick answers
- What is Brevibloc?
- Brevibloc is a brand name of Esmolol hydrochloride, a prescription medicine. The FDA NDC Directory lists 8 Brevibloc products in 2 strengths and forms.
- Who makes Brevibloc?
- Baxter Hlthcare holds the FDA application for Brevibloc (NDA019386, approved December 31, 1986). 1 other company (repackagers or distributors) also list Brevibloc products.
- Is there a generic or store brand of Brevibloc?
- Yes. The FDA NDC Directory lists 14 other products with the same active ingredients, strength and form as a Brevibloc product, 9 of them generic. Ask your pharmacist whether one is right for you.
- Has Brevibloc been recalled?
- FDA enforcement reports list 2 recalls of Brevibloc products; the newest started April 12, 2016. A recall usually concerns specific lots, not every product.
What Brevibloc is
Each Brevibloc 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.
Esmolol hydrochloride · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| esmolol hydrochloride 10 mg/mL injection (intravenous) | Brevibloc | 9 products, 8 companies | DailyMed |
| esmolol hydrochloride 20 mg/mL injection (intravenous) | Brevibloc | 5 products, 4 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Esmolol hydrochloride →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA019386 | Baxter Hlthcare | December 31, 1986 | 8 |
Companies that list Brevibloc
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Brevibloc products.
- Baxter Healthcare Company7 products
- Henry Schein, Inc1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 12, 2016 · Class II · Terminated · D-0852-2016
Discoloration: presence of atypical yellow discoloration of the solution .
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87 — Baxter Healthcare Corp.
-
June 16, 2014 · Class II · Terminated · D-1413-2014
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter — Baxter Healthcare Corp.
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.