Prescription medicine
Bisoprolol First approved as Zebeta
Bisoprolol (Zebeta) is a prescription medicine with an FDA approval on record since 1992. FDA's NDC Directory lists it from 24 generic labelers, and pharmacies paid $0.114 per bisoprolol fumarate 5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the bisoprolol FDA label on DailyMed (effective March 11, 2026, Micro Labs Limited); the NDA 19982 record on Drugs@FDA; every bisoprolol label on DailyMed.
Highlights of the record
FDA label of March 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBisoprolol fumarate tablets are indicated in the management of hypertension.
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- July 31, 1992 Zebeta, Teva Branded Pharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first November 16, 2000; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 24 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.114 per tablet Bisoprolol fumarate 5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest October 2, 2017
- FAERS reports
- 135,060 through July 30, 2026
What is bisoprolol used for?
From the label: indications and usageBisoprolol fumarate tablets are indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.
Conditions named in the indications of bisoprolol's FDA labels, with every medicine labeled for each:
From other bisoprolol labelsHigh blood pressure: INDICATIONS AND USAGE Bisoprolol fumarate tablets are indicated in the management of hypertension.
FDA pharmacologic class: beta-Adrenergic Blocker.
Source: FDA drug label (Bisoprolol), Micro Labs Limited, effective March 11, 2026 (SPL set c3ee566c-74c4-45f4-a947-526a7313e326), via openFDA; the full label on DailyMed
Is there a generic for bisoprolol (Zebeta)?
The FDA approved the first generic bisoprolol on November 16, 2000. 13 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists bisoprolol from 24 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1992 earliest approval on file
- 2000 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for bisoprolol (Zebeta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.114 per Bisoprolol fumarate 5 mg tablet, down 39% from $0.189 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Bisoprolol fumarate 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bisoprolol fumarate 10 mg tablet | Generic | $0.160 per tablet | $4.81 | -28% |
| Bisoprolol fumarate 2.5 mg tablet | Generic | $2.52 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $75.60 | -2% |
| Bisoprolol fumarate 5 mg tablet | Generic | $0.114 per tablet | $3.43 | -39% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has bisoprolol been recalled?
The FDA's Enforcement Report lists 2 recalls naming bisoprolol since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 2, 2017 | Class II | Unichem Pharmaceuticals Usa Inc | Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; BISOPROLOL FUMARATE Tablet, 5 mg may be potentially mislabeled as: ESTROPIPATE, Tablet, 0.75 mg, NDC 00591041401, Pedigree: AD34934_4 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bisoprolol label say about other medicines?
The bisoprolol label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name bisoprolol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cimetidine | drug interactions | Pharmacokinetic studies document no clinically relevant interactions with other agents given concomitantly, including thiazide diuretics and cimetidine. |
| Clonidine | drug interactions | In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that bisoprolol fumarate be discontinued for several days before the withdrawal of clonidine. |
| Diltiazem | drug interactions | Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently. |
| Disopyramide | drug interactions | Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently. |
| Epinephrine | drug interactions | Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. |
| Rifampin | drug interactions | Concurrent use of rifampin increases the metabolic clearance of bisoprolol fumarate, resulting in a shortened elimination half-life of bisoprolol fumarate. |
| Verapamil | drug interactions | Bisoprolol fumarate should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently. |
| Warfarin | drug interactions | There was no effect of bisoprolol fumarate on prothrombin time in patients on stable doses of warfarin. |
Source: FDA drug label (Bisoprolol), Micro Labs Limited, effective March 11, 2026 (SPL set c3ee566c-74c4-45f4-a947-526a7313e326), via openFDA; the full label on DailyMed
What do FAERS reports show for bisoprolol?
The FDA Adverse Event Reporting System holds 135,060 reports that list bisoprolol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14,918 are coded as a death and 74,816 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as bisoprolol?
74 other medicines are given the same way (oral) and in the same FDA class as bisoprolol or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Metoprolol | High blood pressure | 64 labelers | $0.085 per tablet 100 mg tablet | A presentation being discontinued |
| Propranolol | High blood pressure | 38 labelers | $0.0493 per tablet 20 mg tablet | In shortage |
| Carvedilol | High blood pressure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Atenolol | High blood pressure | 35 labelers | $0.0217 per tablet 25 mg tablet | No current entry |
| Labetalol | High blood pressure | 31 labelers | $0.215 per tablet 300 mg tablet | No current entry |
| Nebivolol | High blood pressure | 23 labelers | $0.141 per tablet 10 mg tablet | A presentation being discontinued |
| Nadolol | High blood pressure | 16 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Pindolol | High blood pressure | 8 labelers | $0.854 per tablet 10 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as bisoprolol
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does bisoprolol compare with medicines for the same use?
19 side-by-side pages set bisoprolol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to bisoprolol
- 74 medicines for the same use
- Other beta blockers
- the pharmacologic class, with prices and generics
- Bisoprolol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other