Quick answers
- What is Nebivolol used for?
- The FDA-approved label (Bystolic, Allergan, Inc., August 1, 2024) says: “1. INDICATIONS 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 Hypertension BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nebivolol have a boxed warning?
- No. None of the 43 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nebivolol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nebivolol been recalled?
- FDA enforcement reports list 5 recalls of products of this medicine; the newest started November 18, 2025 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Nebivolol?
- 24 companies list prescription products of Nebivolol in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Cadila Pharmaceuticals Limited.
What Nebivolol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. INDICATIONS 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 Hypertension BYSTOLIC is indicated for the treatment of hypertension, to lower blood pressure […]. …
— FDA label: Bystolic, Allergan, Inc., effective August 1, 2024. Read the full label on DailyMed →
The FDA has 43 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 43 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 98 in the FDA NDC Directory |
| Brand names | Bystolic |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| nebivolol 10 mg tablet | Generic | $0.1469 per tablet |
| nebivolol 2.5 mg tablet | Generic | $0.1145 per tablet |
| nebivolol 20 mg tablet | Generic | $0.1717 per tablet |
| nebivolol 5 mg tablet | Generic | $0.1153 per tablet |
| nebivolol hydrochloride 10 mg tablet | Generic | $0.1469 per tablet |
| nebivolol hydrochloride 10 mg tablet | Brand: Bystolic | $6.41 per tablet |
| nebivolol hydrochloride 2.5 mg tablet | Generic | $0.1145 per tablet |
| nebivolol hydrochloride 2.5 mg tablet | Brand: Bystolic | $6.44 per tablet |
| nebivolol hydrochloride 20 mg tablet | Generic | $0.1717 per tablet |
| nebivolol hydrochloride 20 mg tablet | Brand: Bystolic | $6.42 per tablet |
| nebivolol hydrochloride 5 mg tablet | Generic | $0.1153 per tablet |
| nebivolol hydrochloride 5 mg tablet | Brand: Bystolic | $6.45 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 this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bryant Ranch Prepack13 products
- A-S Medication Solutions6 products
- Cadila Pharmaceuticals Limited4 products
- Modavar Pharmaceuticals LLC4 products
- NorthStar RxLLC4 products
- Camber Pharmaceuticals, Inc.4 products
- Macleods Pharmaceuticals Limited4 products
- ANI Pharmaceuticals, Inc.4 products
- Ascend Laboratories, LLC4 products
- Lifestar Pharma LLC4 products
- Novadoz Pharmaceuticals LLC4 products
- Unichem Pharmaceuticals (USA), Inc.4 products
- Golden State Medical Supply, Inc.4 products
- Allergan, Inc.4 products
- Apnar Pharma LP4 products
- AvKARE4 products
- Aurobindo Pharma Limited4 products
- Glenmark Pharmaceuticals Inc., USA4 products
- Solco Healthcare US, LLC4 products
- Major Pharmaceuticals4 products
- Remedyrepack Inc.3 products
- American Health Packaging2 products
- Proficient Rx LP1 product
- Direct_Rx1 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 |
|---|---|---|---|
| NDA021742 BYSTOLIC | Allergan | December 17, 2007 | 10, latest June 16, 2023 2023: Labeling · 2017: Labeling · 2015: Manufacturing (CMC) |
Generic approvals (12)
- ANDA203659Ani Pharms · April 16, 2015
- ANDA203828Indchemie Health · July 29, 2015
- ANDA203821Glenmark Pharms Ltd · May 25, 2017
- ANDA203825Hetero Labs Ltd III · November 3, 2020
- ANDA208717Cadila Pharms Ltd · December 17, 2021
- ANDA211053Aurobindo Pharma Ltd · December 17, 2021
- ANDA213830Unichem · March 15, 2022
- ANDA212682Prinston Inc · April 7, 2022
- ANDA216172Mankind Pharma · November 14, 2022
- ANDA216568Regcon Holdings · March 30, 2023
- ANDA217397Msn · October 1, 2024
- ANDA212661Macleods Pharms · January 28, 2025
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.
-
November 18, 2025 · Class III · Ongoing · D-0222-2026
Cross Contamination with Other Products
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, NDC 42291-874-90. — Glenmark Pharmaceuticals Inc., USA
-
December 6, 2024 · Class II · Ongoing · D-0149-2025
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
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 — Aurobindo Pharma USA Inc
-
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
-
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
-
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
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) — Bystolic, Allergan, Inc., effective August 1, 2024; 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 →