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Brand-name prescription medicine

Betapace

Generic name: Sotalol hydrochloride

FDA application holder: Legacy

Strengths and generic versions Official label

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.

At a glance

3Strengths and forms
68Same medicine, other names
1992FDA approval
0Recalls (FDA reports)

Quick answers

What is Betapace?
Betapace is a brand name of Sotalol hydrochloride, a prescription medicine. The FDA NDC Directory lists 3 Betapace products in 3 strengths and forms.
Who makes Betapace?
Legacy holds the FDA application for Betapace (NDA019865, approved October 30, 1992).
Is there a generic or store brand of Betapace?
Yes. The FDA NDC Directory lists 68 other products with the same active ingredients, strength and form as a Betapace product, 65 of them generic. Ask your pharmacist whether one is right for you.
Has Betapace been recalled?
No recall linked to Betapace products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Betapace is

Each Betapace 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.

Sotalol hydrochloride · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
sotalol hydrochloride 120 mg
tablet (oral)		 Betapace 18 products, 12 companies DailyMed
sotalol hydrochloride 160 mg
tablet (oral)		 Betapace 15 products, 10 companies DailyMed
sotalol hydrochloride 80 mg
tablet (oral)		 Betapace 35 products, 18 companies DailyMed

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

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Betapace products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA019865LegacyOctober 30, 19923

Companies that list Betapace

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

Recalls

No recall linked to Betapace products (by their NDC code or label) appears in the FDA enforcement reports.

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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