FDA.reportPublic FDA data

Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet

RxCUI
1922720
RxNorm name
Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet
Display name
Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet
Full name
Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:49

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SotalolSOTALOL HYDROCHLORIDEUNICHEM PHARMACEUTICALS (USA), INC.56879738-8662-4f5c-8386-761ab2b5e46f2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1922720
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEApotex Corp.1a56c82e-7ecd-43b0-2899-f89e47adf7db2025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1922720
Sotalol hydrochlorideSOTALOL HYDROCHLORIDEEpic Pharma, LLCc0a34c56-9641-4592-9754-bcc233ec86b62025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1922720
BETAPACESOTALOL HYDROCHLORIDELegacy Pharma USA, Inc.a6a7702f-36c9-45db-b640-453dc324baee2024-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1922720
SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDEAurobindo Pharma Limited6f3145d7-f3c9-4456-a77d-d04c54f246682024-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1922720

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 9 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
1a56c82e-7ecd-43b0-2899-f89e47adf7dbsotalol HCl AF 120 MG Oral Tablet [PSN] · Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [SCD] · sotalol hydrochloride AF 120 MG Oral Tablet [SY]317These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE/SOTALOL HYDROCHLORIDE AF TABLETS safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE/SOTALOL HYDROCHLORIDE AF TABLETS SOTALOL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1992 SOTALOL HYDROCHLORIDE AF tablets, for oral use Initial U.S. Approval: 199220250710
c0a34c56-9641-4592-9754-bcc233ec86b6sotalol HCl AF 120 MG Oral Tablet [PSN] · Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [SCD] · sotalol hydrochloride AF 120 MG Oral Tablet [SY]39These highlights do not include all the information needed to use sotalol hydrochloride tablets safely and effectively. See full prescribing information for sotalol hydrochloride tablets Sotalol hydrochloride tablets USP (AF), for oral use Initial U.S. Approval: 199220250604
afce2787-8899-4098-87c8-f1e8dd19e6ddsotalol HCl AF 120 MG Oral Tablet [PSN] · Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [SCD] · sotalol hydrochloride AF 120 MG Oral Tablet [SY]36These highlights do not include all the information needed to use BETAPACE ® /BETAPACE AF safely and effectively. See full prescribing information for BETAPACE/BETAPACE AF. BETAPACE (sotalol hydrochloride) tablets, for oral use BETAPACE AF (sotalol hydrochloride) tablets, for oral use Initial U.S. Approval: 199220230615
56879738-8662-4f5c-8386-761ab2b5e46fsotalol HCl AF 120 MG Oral Tablet [PSN] · Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [SCD] · sotalol hydrochloride AF 120 MG Oral Tablet [SY]35These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS USP/SOTALOL HYDROCHLORIDE TABLETS USP (AF) safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS USP/SOTALOL HYDROCHLORIDE TABLETS USP (AF).Sotalol hydrochloride tablets USP, for oral use Sotalol hydrochloride tablets USP (AF), for oral use Initial U.S. Approval: 199220260122
7c9cc47c-1cb2-405d-8c8a-50226482ede2sotalol HCl AF 120 MG Oral Tablet [PSN] · Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [SCD] · sotalol hydrochloride AF 120 MG Oral Tablet [SY]34Sotalol Hydrochloride Tablets - AF20210108
a6a7702f-36c9-45db-b640-453dc324baeesotalol HCl AF 120 MG Oral Tablet [PSN] · Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [SCD] · sotalol hydrochloride AF 120 MG Oral Tablet [SY]32These highlights do not include all the information needed to use BETAPACE ® /BETAPACE AF safely and effectively. See full prescribing information for BETAPACE/BETAPACE AF. BETAPACE (sotalol hydrochloride) tablets, for oral use Initial U.S. Approval: 1992 BETAPACE AF (sotalol hydrochloride) tablets, for oral use Initial U.S. Approval: 199220241216
6f3145d7-f3c9-4456-a77d-d04c54f24668sotalol HCl AF 120 MG Oral Tablet [PSN] · Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [SCD] · sotalol hydrochloride AF 120 MG Oral Tablet [SY]32These highlights do not include all the information needed to use SOTALOL HYDROCHLORIDE TABLETS (AF) safely and effectively. See full prescribing information for SOTALOL HYDROCHLORIDE TABLETS (AF). SOTALOL HYDROCHLORIDE tablets (AF), for oral use Initial U.S. Approval: 199220241003
2577dd8d-ab1b-4a55-990a-18c69395edfesotalol HCl AF 120 MG Oral Tablet [PSN] · Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [SCD] · sotalol hydrochloride AF 120 MG Oral Tablet [SY]32Sotalol Hydrochloride Tablets, USP (AF) 80 mg, 120 mg, and 160 mg20240117
6616d1a2-09a6-429c-8d19-0ac6354980bbsotalol HCl AF 120 MG Oral Tablet [PSN] · Atrial Fibrillation sotalol hydrochloride 120 MG Oral Tablet [SCD] · sotalol hydrochloride AF 120 MG Oral Tablet [SY]31SOTALOL HYDROCHLORIDE TABLETS (AF)20070122