BETAPACE AF — Tablet

Overview

Brand name

BETAPACE AF

Generic name

sotalol hydrochloride

Dosage form

Tablet

Route

Oral

Marketing category

NDA · NDA

Labeler

Legacy Pharma USA, Inc.

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

3

NDC product codes

3

Packages

3

Data completeness

54% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Sotalol Hydrochloride	120 mg/1	1923426	View
Sotalol Hydrochloride	160 mg/1	1923426	View
Sotalol Hydrochloride	80 mg/1	1923426	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Adrenergic beta-Antagonists [MoA]	MoA	All 72 members
Antiarrhythmic [EPC]	EPC	All 48 members
Cardiac Rhythm Alteration [PE]	PE	4 members — no class page

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

019865

Application type

NDA · New Drug Application

Approval date

October 30, 1992

Sponsor

LEGACY

Products on application

5

Submissions recorded

18

Products approved under application 019865.
Product	Trade name	Form	Ingredient	Status	TE	Flags
019865-001	BETAPACE	TABLET	SOTALOL HYDROCHLORIDE	Prescription	AB	RLD
019865-002	BETAPACE	TABLET	SOTALOL HYDROCHLORIDE	Prescription	AB	RLD RS
019865-003	BETAPACE	TABLET	SOTALOL HYDROCHLORIDE	Prescription	AB	RLD
019865-004	BETAPACE	TABLET	SOTALOL HYDROCHLORIDE	Discontinued	—
019865-005	BETAPACE	TABLET	SOTALOL HYDROCHLORIDE	Prescription	AB	RLD

Therapeutic equivalence

Source: Orange Book

TE code

AB

Reference Listed Drug

Yes

Reference Standard

Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 019865.
Type	No.	Action	Status	Date	Review
Supplement	26	Labeling	Approved	June 15, 2023	Standard
Supplement	22	Labeling	Approved	June 3, 2021	Standard
Supplement	21	Labeling	Approved	May 10, 2016	Standard
Supplement	20	Labeling	Approved	August 17, 2011	Unknown
Supplement	19	Labeling	Approved	February 3, 2011	Unknown
Supplement	10	Efficacy	Approved	October 1, 2001	Standard
Supplement	14	Manufacturing (CMC)	Approved	July 26, 2001	Priority
Supplement	12	Manufacturing (CMC)	Approved	November 22, 2000	Priority
Supplement	11	Labeling	Approved	July 7, 2000	Standard
Supplement	8	Labeling	Approved	August 23, 1999	Standard
Supplement	9	Manufacturing (CMC)	Approved	April 9, 1999	Priority
Supplement	6	Manufacturing (CMC)	Approved	December 4, 1995	Priority
Supplement	5	Labeling	Approved	July 26, 1995	Standard
Supplement	3	Manufacturing (CMC)	Approved	September 6, 1994	Priority
Supplement	4	Labeling	Approved	April 20, 1994	Standard
Supplement	2	Manufacturing (CMC)	Approved	April 20, 1994	Priority
Supplement	1	Manufacturing (CMC)	Approved	April 13, 1993	Priority
Original application	1	Type 1 - New Molecular Entity	Approved	October 30, 1992	Priority

Review documents

0 · Supplement · June 23, 2023
0 · Supplement · June 16, 2023
0 · Supplement · June 8, 2021
0 · Supplement · June 7, 2021
0 · Supplement · May 17, 2016
0 · Supplement · May 11, 2016
0 · Supplement · August 24, 2011
0 · Supplement · August 18, 2011
0 · Supplement · February 9, 2011
0 · Supplement · February 4, 2011
0 · Supplement · June 19, 2002
0 · Supplement · October 1, 2001
0 · Supplement · October 1, 2001

Adverse event reports

Source: openFDA FAERS

16,549

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SOTALOL HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
83107-008-60	83107-008	Legacy Pharma USA, Inc.	60 TABLET in 1 BOTTLE (83107-008-60)	September 1, 2016
83107-009-60	83107-009	Legacy Pharma USA, Inc.	60 TABLET in 1 BOTTLE (83107-009-60)	September 1, 2016
83107-010-60	83107-010	Legacy Pharma USA, Inc.	60 TABLET in 1 BOTTLE (83107-010-60)	September 1, 2016
83107-008	83107-008	Legacy Pharma USA, Inc.	—	September 1, 2016
83107-009	83107-009	Legacy Pharma USA, Inc.	—	September 1, 2016
83107-010	83107-010	Legacy Pharma USA, Inc.	—	September 1, 2016

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.