Prescription medicine
Nebivolol Brand names: Bystolic
Nebivolol (Bystolic) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 23 generic labelers, and pharmacies paid $0.141 per nebivolol 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- A presentation discontinued
Check it at the source: the nebivolol FDA label on DailyMed (effective August 1, 2024, Allergan, Inc.); the NDA 21742 record on Drugs@FDA; every nebivolol label on DailyMed.
Highlights of the record
FDA label of August 1, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageINDICATIONS AND USAGE BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure.
Forms and strengths
- 2.5 mg
- 5 mg
- 10 mg
- 20 mg
Tablet.
On the market
- Earliest approval on file
- December 17, 2007 Bystolic, Allergan; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first April 16, 2015; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 23 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.141 per tablet Nebivolol 10 mg tablet
- Shortage (FDA)
- None current 16 past records
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest November 18, 2025; 1 more by firms not listed as its makers
- FAERS reports
- 33,555 through July 30, 2026
What is nebivolol used for?
From the label: indications and usageINDICATIONS AND USAGE BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) 1.1 Hypertension BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure [see Clinical Studies ( 14.1 )]. BYSTOLIC may be used alone or in combination with other antihypertensive agents [see Drug Interactions ( 7 )]. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. […]
Conditions named in the indications of nebivolol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: beta-Adrenergic Blocker.
Source: FDA drug label (Bystolic), Allergan, Inc., effective August 1, 2024 (SPL set 8b8ad213-1dc8-454e-a524-075685c0e1a8), via openFDA; the full label on DailyMed
Is there a generic for nebivolol (Bystolic)?
The FDA approved the first generic nebivolol on April 16, 2015. 18 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists nebivolol from 23 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2007 earliest approval on file
- 2015 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 nebivolol (Bystolic)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.141 per Nebivolol 10 mg tablet, about the same as a year earlier. 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.
- Nebivolol 5 mg tablet (generic)
- Bystolic 10 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nebivolol 10 mg tablet | Generic | $0.141 per tablet | $4.24 | +0.8% |
| Nebivolol 2.5 mg tablet | Generic | $0.117 per tablet | $3.51 | +7% |
| Nebivolol 20 mg tablet | Generic | $0.175 per tablet | $5.25 | -7% |
| Nebivolol 5 mg tablet | Generic | $0.113 per tablet | $3.40 | +3% |
| Bystolic 10 mg tablet | Brand | $6.41 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $192.28 | +4% |
| Bystolic 2.5 mg tablet | Brand | $6.45 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $193.39 | +5% |
| Bystolic 20 mg tablet | Brand | $6.42 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $192.66 | +5% |
| Bystolic 5 mg tablet | Brand | $6.45 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $193.54 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is nebivolol in shortage?
No nebivolol presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 16 records are all marked to be discontinued, the latest updated March 25, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Nebivolol Hydrochloride, Tablet, 10 mg (NDC 13668-355-01) | Torrent Pharmaceuticals Limited | To Be Discontinued | March 25, 2026 |
| Nebivolol Hydrochloride, Tablet, 10 mg (NDC 13668-355-05) | Torrent Pharmaceuticals Limited | To Be Discontinued | March 25, 2026 |
| Nebivolol Hydrochloride, Tablet, 10 mg (NDC 13668-355-30) | Torrent Pharmaceuticals Limited | To Be Discontinued | March 25, 2026 |
| Nebivolol Hydrochloride, Tablet, 10 mg (NDC 13668-355-90) | Torrent Pharmaceuticals Limited | To Be Discontinued | March 25, 2026 |
| Nebivolol Hydrochloride, Tablet, 2.5 mg (NDC 13668-353-01) | Torrent Pharmaceuticals Limited | To Be Discontinued | March 25, 2026 |
| Nebivolol Hydrochloride, Tablet, 2.5 mg (NDC 13668-353-05) | Torrent Pharmaceuticals Limited | To Be Discontinued | March 25, 2026 |
| Nebivolol Hydrochloride, Tablet, 2.5 mg (NDC 13668-353-30) | Torrent Pharmaceuticals Limited | To Be Discontinued | March 25, 2026 |
| Nebivolol Hydrochloride, Tablet, 2.5 mg (NDC 13668-353-90) | Torrent Pharmaceuticals Limited | To Be Discontinued | March 25, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has nebivolol been recalled?
The FDA's Enforcement Report lists 6 recalls naming nebivolol since 2013: 0 Class I (the most serious), 5 Class II, 1 Class III; 2 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of nebivolol and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 18, 2025 | Class III | Glenmark Pharmaceuticals Inc., USA | Cross Contamination with Other Products |
| December 6, 2024 | Class II | Aurobindo Pharma USA Inc | CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit. |
| September 26, 2014 | Class II | Forest Pharmaceuticals Inc | Failed Dissolution Specification; at the 6-month stability time point |
| June 19, 2014 | Class II | Forest Pharmaceuticals Inc | Failed Dissolution Specifications: Drug failed stage III dissolution testing. |
| May 12, 2014 | Class II | Forest Pharmaceuticals Inc | Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: NEBIVOLOL HCL, Tablet, 5 mg may have potentially been mislabeled as one of the following drugs: THYROID, Tablet, 30 mg, NDC 00456045801 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nebivolol label say about other medicines?
The nebivolol label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name nebivolol. 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 |
|---|---|---|
| Clonidine | drug interactions | DRUG INTERACTIONS CYP2D6 enzyme inhibitors may increase nebivolol levels. ( 7.1 ) Reserpine or clonidine may produce excessive reduction of sympathetic activity. ( 7.2 ) Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. |
| Diltiazem | drug interactions | Calcium Channel Blockers BYSTOLIC can exacerbate the effects of 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. |
| Disopyramide | drug interactions | Calcium Channel Blockers BYSTOLIC can exacerbate the effects of 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. |
| Dobutamine | warnings and precautions | The β-blocking effects of BYSTOLIC can be reversed by β-agonists, e.g., dobutamine or isoproterenol. |
| Epinephrine | warnings and precautions | Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reactions. |
| Fluoxetine | drug interactions | Use caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [see Clinical Pharmacology ( 12.5 )]. |
| Isoproterenol | warnings and precautions | The β-blocking effects of BYSTOLIC can be reversed by β-agonists, e.g., dobutamine or isoproterenol. |
| Paroxetine | drug interactions | Use caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [see Clinical Pharmacology ( 12.5 )]. |
| Propafenone | drug interactions | Use caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [see Clinical Pharmacology ( 12.5 )]. |
| Quinidine | drug interactions | Use caution when BYSTOLIC is co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [see Clinical Pharmacology ( 12.5 )]. |
| Verapamil | drug interactions | Calcium Channel Blockers BYSTOLIC can exacerbate the effects of 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. |
Other labels that name nebivolol
Source: FDA drug label (Bystolic), Allergan, Inc., effective August 1, 2024 (SPL set 8b8ad213-1dc8-454e-a524-075685c0e1a8), via openFDA; the full label on DailyMed
What do FAERS reports show for nebivolol?
The FDA Adverse Event Reporting System holds 33,555 reports that list nebivolol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,385 are coded as a death and 13,128 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 nebivolol?
75 other medicines are given the same way (oral) and in the same FDA class as nebivolol 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 |
| Nadolol | High blood pressure | 16 labelers | $0.147 per tablet 20 mg tablet | No current entry |
| Bisoprolol | High blood pressure | 24 labelers | $0.114 per tablet 5 mg tablet | No current entry |
| Bisoprolol and hydrochlorothiazide | High blood pressure | 11 labelers | $0.209 per tablet 10-6.25 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does nebivolol compare with medicines for the same use?
14 side-by-side pages set nebivolol beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to nebivolol
- 75 medicines for the same use
- Other beta blockers
- the pharmacologic class, with prices and generics
- Nebivolol side effects
- the label's list beside FAERS reports
- Nebivolol shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other