Nebivolol
Nebivolol is a beta blocker (a type of heart and blood pressure medicine) taken by mouth as a tablet to treat high blood pressure (hypertension).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 42 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Nebivolol (Bystolic) is a once-daily beta blocker that lowers high blood pressure, and with it the risk of strokes and heart attacks, by slowing the heart and relaxing blood vessels; it is usually an add-on rather than a first choice, has been on the U.S. market since about 2007, and is available as a generic. Most people tolerate it well, many find it easier than older beta blockers, and headache, tiredness and dizziness are the side effects most noticed. The one rule that matters is never stopping it suddenly, which can worsen chest pain or trigger a heart attack or dangerous heart rhythm, so any stop should be a planned taper.
Clinical pearls
- Fluoxetine, paroxetine, quinidine and propafenone can raise nebivolol levels, so mention it before starting any of them.
- With diabetes, nebivolol can hide the fast heartbeat of low blood sugar, so check readings whenever you feel shaky or sweaty.
- Tell any surgeon or anesthesia team you take nebivolol, and do not hold it before surgery unless they say so.
- If you also take clonidine, never stop either one on your own, because coming off clonidine needs a planned sequence with nebivolol.
Patient information guide A plain-language walkthrough of Nebivolol, written from its FDA label.
What Nebivolol is used for
▾
Nebivolol tablets are used for one condition:
- High blood pressure (hypertension), to lower blood pressure and reduce the risk of strokes and heart attacks
- Bystolic, Nebivolol and Nebivolol Hydrochloride tablets can be used alone or with other blood pressure medicines
How Nebivolol works
▾
Nebivolol is a beta blocker. It blocks beta receptors that respond to stress hormones like adrenaline. At lower doses, in most people, it mainly targets beta-1 receptors, which are found mostly in the heart. At higher doses and in people who break it down slowly, it blocks beta-2 receptors too.
How it lowers blood pressure is not fully known. It may slow the heart, ease how hard it squeezes, reduce nerve signals to blood vessels, lower renin, and relax blood vessels.
Nebivolol dosage
▾
Nebivolol tablets are taken by mouth, generally once daily, with or without food. Your prescriber individualizes the dose and may raise it at about 2-week intervals if needed. A lower starting dose is used in severe kidney problems or moderate liver problems.
- Follow your prescriber's directions and the label
- Do not stop suddenly
Dosing details from the FDA-approved label
From the Nebivolol prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Hypertension
- Recommended starting dose for most patients is 5 mg once daily, with or without food, as monotherapy or in combination with other agents
- For patients requiring further reduction in blood pressure, the dose can be increased at 2-week intervals
- Maximum: up to 40 mg
- A more frequent dosing regimen is unlikely to be beneficial
- Severe renal impairment (ClCr less than 30 mL/min)
- Recommended initial dose is 2.5 mg once daily
- Titrate up slowly if needed
- Not studied in patients receiving dialysis
- Moderate hepatic impairment
- Recommended initial dose is 2.5 mg once daily
- Titrate up slowly if needed
- Not studied in severe hepatic impairment; not recommended in that population
- Geriatric patients
- It is not necessary to adjust the dose in the elderly
- CYP2D6 poor metabolizers
- No dose adjustments are necessary
- Clinical effect and safety profile in poor metabolizers were similar to those of extensive metabolizers
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Can be taken with and without food. Individualize to the needs of the patient and monitor during up-titration. ( 2 ) Hypertension: Most patients start at 5 mg once daily. Dose can be increased at 2-week intervals up to 40 mg. ( 2.1 ) 2.1 Hypertension The dose of nebivolol tablets must be individualized to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction in blood pressure, the dose can be increased at 2-week intervals up to 40 mg. A more frequent dosing regimen is unlikely to be beneficial. Renal Impairment In patients with severe renal impairment (ClCr less than 30 mL/min) the recommended initial dose is 2.5 mg once daily; titrate up slowly if needed. Nebivolol tablets have not been studied in patients receiving dialysis [ see Clinical Pharmacology ( 12.4 ) ]. Hepatic Impairment In patients with moderate hepatic impairment, the recommended initial dose is 2.5 mg once daily; titrate up slowly if needed. Nebivolol tablets have not been studied in patients with severe hepatic impairment and Therefore it is not recommended in that population [ see Clinical Pharmacology ( 12.4 ) ]. 2.2 Subpopulations Geriatric Patients It is not necessary to adjust the dose in the elderly [ see use in Specific Populations ( 8.5 ) ]. CYP2D6 Polymorphism No dose adjustments are necessary for patients who are CYP2D6 poor metabolizers. The clinical effect and safety profile observed in poor metabolizers were similar to those of extensive metabolizers [ see Clinical Pharmacology ( 12.3 ) ].
Read the full Dosage and Administration section on DailyMed →
Nebivolol side effects
▾
Most people tolerate nebivolol well. Common side effects include:
Common side effects
- Headache
- Fatigue
- Dizziness
- Nausea
- Diarrhea
- Slow heart rate (bradycardia)
- Trouble sleeping (insomnia)
- Shortness of breath
When to get medical help
- Chest pain that gets worse, a heart attack, or a dangerous heart rhythm, especially if you stop the medicine suddenly
- Severe low blood sugar, which nebivolol can hide the usual warning signs of (such as a fast heartbeat). Seek emergency care if it happens
- Very slow heartbeat, fainting, or severe dizziness
- Wheezing or trouble breathing
- Swelling of the face, lips or throat, hives, or a serious allergic reaction
- Heart failure that gets worse (new swelling, sudden weight gain, or more shortness of breath)
- Symptoms of an overdose, such as a very slow heartbeat or very low blood pressure. Call Poison Control at 800-222-1222
Nebivolol warnings and precautions
▾
- Do not stop suddenly. Doing so can worsen angina, cause a heart attack, or trigger dangerous heart rhythms.
- It can hide signs of low blood sugar, especially in people with diabetes or who are fasting.
- It can mask signs of an overactive thyroid.
- It may worsen poor circulation in the limbs.
- Beta blockers are generally avoided in airway spasm diseases such as asthma.
- People with severe allergic histories may react more strongly and respond less to epinephrine.
- Tell surgical and anesthesia teams you take it.
Nebivolol interactions
▾
Several medicines can change how nebivolol works or add to its effects:
- Other beta blockers: should not be combined
- CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine): raise nebivolol levels
- Verapamil, diltiazem, disopyramide: can overly slow the heart and lower blood pressure
- Digoxin-type drugs: raise the risk of a slow heartbeat
- Reserpine, guanethidine: can overly reduce sympathetic activity
- Clonidine: nebivolol is stopped for several days before clonidine is tapered
Interactions listed in the FDA-approved label
From the Nebivolol prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.): CYP2D6 enzyme inhibitors may increase nebivolol levels. Use caution when co-administered.
- Other β-blockers: The label states not to use nebivolol with other β-blockers. Do not use together.
- Reserpine or guanethidine (catecholamine-depleting drugs): The added β-blocking action of nebivolol may produce excessive reduction of sympathetic activity. Closely monitor patients.
- Clonidine: May produce excessive reduction of sympathetic activity. In patients receiving nebivolol and clonidine, discontinue nebivolol for several days before the gradual tapering of clonidine.
- Digitalis glycosides: Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate; concomitant use can increase the risk of bradycardia.
- Calcium channel blockers (verapamil- or diltiazem-type): Nebivolol can exacerbate the effects of myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists, and may cause excessive reductions in heart rate, blood pressure, and cardiac contractility.
- Antiarrhythmic agents such as disopyramide: Nebivolol can exacerbate the effects of myocardial depressants or inhibitors of AV conduction, such as antiarrhythmic agents like disopyramide.
Read the label’s full interactions text
7. 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. Concomitant use can increase the risk of bradycardia. ( 7.3 ) • Verapamil- or diltiazem-type calcium channel blockers may cause excessive reductions in heart rate, blood pressure, and cardiac contractility. ( 7.4 ) 7.1 CYP2D6 Inhibitors Use caution when nebivolol tablets are co-administered with CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.) [see Clinical Pharmacology ( 12.5 )] . 7.2 Hypotensive Agents Do not use nebivolol tablets with other β-blockers. Closely monitor patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, because the added β-blocking action of nebivolol tablets may produce excessive reduction of sympathetic activity. In patients who are receiving nebivolol tablets and clonidine, discontinue nebivolol tablets for several days before the gradual tapering of clonidine. 7.3 Digitalis Glycosides Both digitalis glycosides and β-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. 7.4 Calcium Channel Blockers Nebivolol tablets 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.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Nebivolol
▾
- Not for people with severe slow heartbeat, heart block beyond first degree, cardiogenic shock, decompensated heart failure, sick sinus syndrome without a pacemaker, or severe liver impairment
- Not for anyone allergic to its ingredients
- Use caution with airway spasm disease, diabetes, thyroid disease, poor circulation, or pheochromocytoma (an α-blocker is started first)
- Lower starting dose for severe kidney impairment or moderate liver impairment
- Pregnancy: data are insufficient. Third-trimester use may affect the newborn
- Breastfeeding is not recommended
- Not established for children
- No dose change needed for older adults
Nebivolol overdose
▾
Overdose most often causes a very slow heartbeat and low blood pressure. It can also cause dizziness, low blood sugar, fatigue, vomiting, wheezing, heart block, and heart failure. Seek emergency care and call Poison Control at 800-222-1222. Treatment is supportive and based on symptoms. Dialysis is not expected to help.
What Nebivolol does in the body
▾
Nebivolol blocks beta-adrenergic receptors. At doses up to 10 mg in most people, it mainly blocks beta-1 receptors. At higher doses and in poor metabolizers, it blocks beta-2 receptors too. It does not block alpha-1 receptors at clinically relevant doses.
How your body processes Nebivolol
▾
Peak blood levels occur about 1.5 to 4 hours after a dose, and food does not change how it is absorbed. The body breaks it down mostly by glucuronidation and partly by the CYP2D6 enzyme. The active form has a half-life of about 12 hours in most people and 19 hours in poor metabolizers. It is cleared through urine and feces as metabolites.
How to store Nebivolol
▾
Store at 20°C to 25°C (68°F to 77°F) . Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Nebivolol
183 supplements and herbal products have documented interactions with Nebivolol in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 5
- Moderate · 151
- Minor · 27
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Nebivolol has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Nebivolol: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Nebivolol — the kind of thing our pharmacy team would talk through with you at the counter.
What is nebivolol used for?
▾
How should I take it?
▾
Can I stop taking it if I feel fine?
▾
What side effects should I expect?
▾
I have diabetes. Is that a problem?
▾
Are there medicines I should watch out for?
▾
Is Nebivolol available over the counter?
▾
When was Nebivolol first available?
▾
Who makes Nebivolol?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Nebivolol on HelloPharmacist
Nebivolol forms and strengths (how it comes)
Nebivolol is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Bystolic tablets treat high blood pressure, alone or with other blood pressure medicines
- Nebivolol and Nebivolol Hydrochloride tablets treat high blood pressure, alone or with other blood pressure medicines
- Bystolic can be taken with or without food, usually once daily
- Nebivolol and Nebivolol Hydrochloride tablets can be taken with or without food, usually once daily
- Bystolic has a lower starting dose for severe kidney problems or moderate liver problems
Nebivolol on the U.S. market: products, makers and brands
How Nebivolol appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
24 companies list 96 Nebivolol product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2007. Brand names on the directory include Bystolic; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Nebivolol is used (Medicaid data)
A general measure of how commonly Nebivolol is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Nebivolol is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Nebivolol prescribed? Of the 1,601 medications we measure, Nebivolol ranks #524 by Medicaid prescriptions — more than 67% of them.
Utilization by Nebivolol product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
nebivolol 5 MG Oral Tablet Most dispensed
Summed across the 15 of 86 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 387013
nebivolol 10 MG Oral Tablet
Summed across the 13 of 83 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 751612
nebivolol 20 MG Oral Tablet
Summed across the 11 of 75 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 827073
nebivolol 2.5 MG Oral Tablet
Summed across the 7 of 60 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 751618
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Nebivolol, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 46 of 304 listed Nebivolol NDCs with Medicaid activity.
Compare Nebivolol products
A representative set of FDA-listed product records for Nebivolol — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 2.5 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 5 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 10 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 20 mg | Oral | A-S Medication Solutions × 2 listings | ANDA | View NDC → |
| 2.5 mg | Oral | Allergan, Inc. | NDA | View NDC → |
| 5 mg | Oral | Allergan, Inc. | NDA | View NDC → |
| 10 mg | Oral | Allergan, Inc. | NDA | View NDC → |
| 20 mg | Oral | Allergan, Inc. | NDA | View NDC → |
| 5 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 10 mg | Oral | American Health Packaging | ANDA | View NDC → |
| 2.5 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | ANI Pharmaceuticals, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Apnar Pharma LP | ANDA | View NDC → |
| 5 mg | Oral | Apnar Pharma LP | ANDA | View NDC → |
| 10 mg | Oral | Apnar Pharma LP | ANDA | View NDC → |
| 20 mg | Oral | Apnar Pharma LP | ANDA | View NDC → |
| 2.5 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 5 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 10 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 20 mg | Oral | Ascend Laboratories, LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 5 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 10 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 20 mg | Oral | Aurobindo Pharma Limited | ANDA | View NDC → |
| 2.5 mg | Oral | AvKARE | ANDA | View NDC → |
| 5 mg | Oral | AvKARE | ANDA | View NDC → |
| 10 mg | Oral | AvKARE | ANDA | View NDC → |
| 20 mg | Oral | AvKARE | ANDA | View NDC → |
| 2.5 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 5 mg | Oral | Bryant Ranch Prepack × 6 listings | ANDA | View NDC → |
| 10 mg | Oral | Bryant Ranch Prepack × 3 listings | ANDA | View NDC → |
| 20 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 2.5 mg | Oral | Cadila Pharmaceuticals Limited | ANDA | View NDC → |
| 5 mg | Oral | Cadila Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Cadila Pharmaceuticals Limited | ANDA | View NDC → |
| 20 mg | Oral | Cadila Pharmaceuticals Limited | ANDA | View NDC → |
| 2.5 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Camber Pharmaceuticals, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Direct_Rx | ANDA | View NDC → |
| 2.5 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 5 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 10 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 20 mg | Oral | Glenmark Pharmaceuticals Inc., USA | ANDA | View NDC → |
| 2.5 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 5 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Golden State Medical Supply, Inc. | ANDA | View NDC → |
| 2.5 mg | Oral | Lifestar Pharma LLC | ANDA | View NDC → |
| 5 mg | Oral | Lifestar Pharma LLC | ANDA | View NDC → |
| 10 mg | Oral | Lifestar Pharma LLC | ANDA | View NDC → |
| 20 mg | Oral | Lifestar Pharma LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 5 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 10 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 20 mg | Oral | Macleods Pharmaceuticals Limited | ANDA | View NDC → |
| 2.5 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 5 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 10 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 20 mg | Oral | Major Pharmaceuticals | ANDA | View NDC → |
| 2.5 mg | Oral | Modavar Pharmaceuticals LLC | ANDA | View NDC → |
| 5 mg | Oral | Modavar Pharmaceuticals LLC | ANDA | View NDC → |
| 10 mg | Oral | Modavar Pharmaceuticals LLC | ANDA | View NDC → |
| 20 mg | Oral | Modavar Pharmaceuticals LLC | ANDA | View NDC → |
| 2.5 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 5 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 10 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 20 mg | Oral | NorthStar RxLLC | ANDA | View NDC → |
| 2.5 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 5 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 10 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 20 mg | Oral | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 5 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 5 mg | Oral | Remedyrepack Inc. × 3 listings | ANDA | View NDC → |
| 2.5 mg | Oral | Solco Healthcare US, LLC | ANDA | View NDC → |
| 5 mg | Oral | Solco Healthcare US, LLC | ANDA | View NDC → |
| 10 mg | Oral | Solco Healthcare US, LLC | ANDA | View NDC → |
| 20 mg | Oral | Solco Healthcare US, LLC | ANDA | View NDC → |
| 2.5 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 5 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 10 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
| 20 mg | Oral | Unichem Pharmaceuticals (USA), Inc. | ANDA | View NDC → |
Showing 96 of 96 products — FDA National Drug Code Directory. See every product, package size and price: browse all 96 Nebivolol NDCs →
Nebivolol side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Nebivolol — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Nebivolol in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Nebivolol FDA approval history
How Nebivolol went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Nebivolol recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 2 Nebivolol recalls since July 2021. Both are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for Avkare, Pulaski, TN 38478, Product of Italy… Lots: Lot# 17240988; Exp. 05/31/2026 FDA record D-0222-2026 →
- Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30 Lots: Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027 FDA record D-0149-2025 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 31555 1 dose form · 4 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 393308In current FDA listings
Look up RxCUI 31555 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Nebivolol supply and shortage status
Whether Nebivolol is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Nebivolol costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 5 mg | $5.30–$6.45 per tablet | NDC details & price history |
| Tablet · Oral | 10 mg | $5.86–$6.41 per tablet | NDC details & price history |
| Tablet · Oral | 2.5 mg | $5.31–$6.45 per tablet | NDC details & price history |
| Tablet · Oral | 20 mg | $5.31–$6.42 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Nebivolol brand names
Nebivolol is sold under one brand name in the FDA directory — Bystolic. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Nebivolol: manufacturers and labelers
24 companies list Nebivolol products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, ANI Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Nebivolol drug class (RxNorm)
Nebivolol belongs to the beta-Adrenergic Blocker class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Nebivolol page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Solco Healthcare US, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →