Quick answers
- What is Esmolol hydrochloride used for?
- The FDA-approved label (Brevibloc, Henry Schein, Inc, August 6, 2026) says: “Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Esmolol hydrochloride have a boxed warning?
- No. None of the 21 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Esmolol hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Esmolol hydrochloride been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 12, 2016 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Esmolol hydrochloride?
- 14 companies list prescription products of Esmolol hydrochloride in the FDA NDC Directory, including Baxter Healthcare Company, HF Acquisition Co LLC, DBA HealthFirst and WG Critical Care, LLC.
What Esmolol hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. …
— FDA label: Brevibloc, Henry Schein, Inc, effective August 6, 2026. Read the full label on DailyMed →
The FDA has 21 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection · Injection, solution |
|---|---|
| Route | Intravenous |
| Prescription products | 36 in the FDA NDC Directory |
| Brand names | Brevibloc, Esmolol Hydrochloride in Water |
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.
- Baxter Healthcare Company7 products
- HF Acquisition Co LLC, DBA HealthFirst4 products
- WG Critical Care, LLC4 products
- Henry Schein, Inc.3 products
- Mylan Institutional LLC3 products
- Eugia US LLC3 products
- Medical Purchasing Solutions, LLC2 products
- Fresenius Kabi USA, LLC2 products
- Sagent Pharmaceuticals2 products
- Amneal Pharmaceuticals LLC2 products
- Baxter Healthcare Corporation1 product
- ProPharma Distribution1 product
- Gland Pharma Limited1 product
- Remedyrepack Inc.1 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 |
|---|---|---|---|
| NDA019386 BREVIBLOC, BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, BREVIBLOC IN PLASTIC CONTAINER | Baxter Hlthcare | December 31, 1986 | 30, latest September 23, 2025 2025: Manufacturing (CMC) · 2023: Labeling · 2015: Manufacturing (CMC) |
| NDA205703 ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER | Hq Spclt Pharma | April 7, 2016 | 1, latest May 2, 2024 2024: Labeling |
Generic approvals (9)
- ANDA076474Mylan Institutional · May 2, 2005
- ANDA076573Fresenius Kabi USA · May 2, 2005
- ANDA205520Eugia Pharma · July 23, 2015
- ANDA206608Mylan Labs Ltd · June 8, 2018
- ANDA207107Sagent Pharms Inc · June 8, 2018
- ANDA208538Gland · August 14, 2019
- ANDA216244Eugia Pharma · March 21, 2022
- ANDA214172Hq Spclt Pharma · December 2, 2022
- ANDA216603Amneal · December 13, 2022
Shortage status
The FDA drug shortage list does not show these products.
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.
-
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.
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) — Brevibloc, Henry Schein, Inc, effective August 6, 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 →