Quick answers
- What is Sotalol hydrochloride used for?
- The FDA-approved label (Betapace, Legacy Pharma USA, Inc., December 16, 2024) says: “Betapace/Betapace AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) Limitations of Use Betapace has not been shown to enhance survival in patients with life threatening ventricular arrhythmias Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sotalol hydrochloride have a boxed warning?
- Yes. The FDA label for Betapace has a boxed warning (“WARNING: LIFE-THREATENING PROARRHYTHMIA”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Sotalol hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sotalol hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sotalol hydrochloride?
- 21 companies list prescription products of Sotalol hydrochloride in the FDA NDC Directory, including Bryant Ranch Prepack, Apotex Corp. and Unichem Pharmaceuticals (USA), Inc..
What Sotalol hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Betapace/Betapace AF is an antiarrhythmic indicated for: the treatment of life-threatening ventricular arrhythmias the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) Limitations of Use Betapace has not been shown to enhance survival in patients with life threatening ventricular arrhythmias Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL …
— FDA label: Betapace, Legacy Pharma USA, Inc., effective December 16, 2024. Read the full label on DailyMed →
The FDA has 44 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.
This label has a boxed warning. Its heading: WARNING: LIFE-THREATENING PROARRHYTHMIA
. Read it on the full label →
44 of 44 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Solution · Injection |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 80 in the FDA NDC Directory |
| Brand names | Betapace, Sotalol Hydrochloride Af, Betapace Af, Sotylize |
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 |
|---|---|---|
| sotalol hydrochloride 120 mg tablet | Generic | $0.1048 per tablet |
| sotalol hydrochloride 160 mg tablet | Generic | $0.1300 per tablet |
| sotalol hydrochloride 240 mg tablet | Generic | $0.2074 per tablet |
| sotalol hydrochloride 5 mg/mL solution | Brand: Sotylize | $2.31–$2.32 per mL 2 packages, lowest to highest |
| sotalol hydrochloride 80 mg tablet | Generic | $0.0706 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 Prepack19 products
- Apotex Corp.7 products
- Unichem Pharmaceuticals (USA), Inc.6 products
- Legacy Pharma USA Inc.6 products
- Aphena Pharma Solutions - Tennessee, LLC5 products
- AiPing Pharmaceutical, Inc.4 products
- Teva Pharmaceuticals USA, Inc.4 products
- Oxford Pharmaceuticals, LLC4 products
- Proficient Rx LP4 products
- PD-Rx Pharmaceuticals, Inc.4 products
- Epic Pharma, LLC3 products
- Aurobindo Pharma Limited3 products
- A-S Medication Solutions2 products
- AvPAK2 products
- Golden State Medical Supply, Inc.1 product
- American Health Packaging1 product
- Major Pharmaceuticals1 product
- Azurity Pharmaceuticals, Inc.1 product
- Northwind Health Company, LLC1 product
- Cardinal Health 107, LLC1 product
- ALTATHERA Pharmaceuticals, LLC1 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 |
|---|---|---|---|
| NDA019865 BETAPACE | Legacy | October 30, 1992 | 17, latest June 15, 2023 2023: Labeling · 2021: Labeling · 2016: Labeling |
| NDA022306 SOTALOL HYDROCHLORIDE | Altathera Pharms LLC | July 2, 2009 | 5, latest July 23, 2025 2025: Efficacy · 2023: Labeling · 2020: Efficacy |
| NDA205108 SOTYLIZE | Azurity | October 22, 2014 | 2, latest January 12, 2024 2024: Labeling · 2015: Manufacturing (CMC) |
Generic approvals (9)
- ANDA075429Teva · May 1, 2000
- ANDA075500Aiping Pharm Inc · April 27, 2001
- ANDA076140Apotex · September 26, 2002
- ANDA076214Apotex · August 27, 2003
- ANDA075563Oxford Pharms · November 7, 2003
- ANDA077070Epic Pharma LLC · November 4, 2005
- ANDA077616Aurobindo Pharma USA · February 7, 2007
- ANDA207428Regcon Holdings · October 21, 2016
- ANDA207429Regcon Holdings · November 2, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Betapace, Legacy Pharma USA, Inc., effective December 16, 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 →