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Brand-name prescription medicine

Bystolic

Generic name: Nebivolol

FDA application holder: Allergan

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Bystolic?
Bystolic is a brand name of Nebivolol, a prescription medicine. The FDA NDC Directory lists 4 Bystolic products in 4 strengths and forms.
Who makes Bystolic?
Allergan holds the FDA application for Bystolic (NDA021742, approved December 17, 2007).
Is there a generic or store brand of Bystolic?
Yes. The FDA NDC Directory lists 79 other products with the same active ingredients, strength and form as a Bystolic product, 79 of them generic. Ask your pharmacist whether one is right for you.
What do pharmacies pay for Bystolic?
CMS lists a National Average Drug Acquisition Cost (NADAC) for 4 Bystolic strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
Has Bystolic been recalled?
FDA enforcement reports list 3 recalls of Bystolic products; the newest started September 26, 2014. A recall usually concerns specific lots, not every product.

What Bystolic is

Each Bystolic 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.

Nebivolol · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
nebivolol hydrochloride 10 mg
tablet (oral)
Bystolic 20 products, 18 companies DailyMed
nebivolol hydrochloride 2.5 mg
tablet (oral)
Bystolic 17 products, 17 companies DailyMed
nebivolol hydrochloride 20 mg
tablet (oral)
Bystolic 18 products, 17 companies DailyMed
nebivolol hydrochloride 5 mg
tablet (oral)
Bystolic 24 products, 20 companies DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Nebivolol →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Bystolic products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA021742AllerganDecember 17, 20074

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Bystolic, by strength and form
Strength and formGeneric or brandPharmacies pay
nebivolol hydrochloride 10 mg
tablet
Brand: Bystolic $6.41 per tablet
Generic of the same strength and form: $0.1469 per tablet
nebivolol hydrochloride 2.5 mg
tablet
Brand: Bystolic $6.44 per tablet
Generic of the same strength and form: $0.1145 per tablet
nebivolol hydrochloride 20 mg
tablet
Brand: Bystolic $6.42 per tablet
Generic of the same strength and form: $0.1717 per tablet
nebivolol hydrochloride 5 mg
tablet
Brand: Bystolic $6.45 per tablet
Generic of the same strength and form: $0.1153 per tablet

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list Bystolic

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Bystolic products.

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.

  1. September 26, 2014 · Class II · Terminated · D-0036-2015

    Failed Dissolution Specification; at the 6-month stability time point

    Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07 — Forest Pharmaceuticals Inc

  2. June 19, 2014 · Class II · Terminated · D-1412-2014

    Failed Dissolution Specifications: Drug failed stage III dissolution testing.

    Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only. Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07. — Forest Pharmaceuticals Inc

  3. May 12, 2014 · Class II · Terminated · D-1348-2014

    Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.

    Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laborato — Forest Pharmaceuticals Inc

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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.

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