Quick answers
- What is Betapace Af?
- Betapace Af is a brand name of Sotalol hydrochloride, a prescription medicine. The FDA NDC Directory lists 3 Betapace Af products in 3 strengths and forms.
- Who makes Betapace Af?
- Legacy holds the FDA application for Betapace Af (NDA019865, approved October 30, 1992).
- Is there a generic or store brand of Betapace Af?
- Yes. The FDA NDC Directory lists 68 other products with the same active ingredients, strength and form as a Betapace Af product, 65 of them generic. Ask your pharmacist whether one is right for you.
- Has Betapace Af been recalled?
- No recall linked to Betapace Af products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Betapace Af is
Each Betapace Af 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 form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| sotalol hydrochloride 120 mg tablet (oral) | Betapace Af | 18 products, 12 companies | DailyMed |
| sotalol hydrochloride 160 mg tablet (oral) | Betapace Af | 15 products, 10 companies | DailyMed |
| sotalol hydrochloride 80 mg tablet (oral) | Betapace Af | 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.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA019865 | Legacy | October 30, 1992 | 3 |
Companies that list Betapace Af
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Betapace Af products.
- Legacy Pharma USA, Inc.3 products
Recalls
No recall linked to Betapace Af products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- 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 labeling (SPL, 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
- 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.