FDA.reportPublic FDA data

SOTALOL HYDROCHLORIDE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2015-04-03
Label type
Indexing - product concept
Version
1
Source
full-release
Hydrated at
2026-06-05 00:14:08

Label at a glance#

ProductSOTALOL HYDROCHLORIDE
Active ingredientSOTALOL HYDROCHLORIDE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
SOTALOL HYDROCHLORIDEHEC37C70XXACTIB

Source Document#

Source XML

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 3 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEA-S Medication Solutions7cb4879f-31e7-4862-bc0c-d439e592d81c2026-08-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sotalol Hydrochloride
generic name: SOTALOL HYDROCHLORIDE
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack9a36d95c-6e93-4e57-befe-b5274f3592442026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sotalol Hydrochloride
generic name: SOTALOL HYDROCHLORIDE
SotalolSOTALOL HYDROCHLORIDEBryant Ranch Prepackc824f6b2-80c5-45a6-a491-4c14c9f5e33d2026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SOTALOL HYDROCHLORIDE
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEAmerican Health Packaging4614480b-b36e-4dbd-9fc0-d083890d297d2026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sotalol Hydrochloride
generic name: SOTALOL HYDROCHLORIDE
SotalolSOTALOL HYDROCHLORIDEUNICHEM PHARMACEUTICALS (USA), INC.56879738-8662-4f5c-8386-761ab2b5e46f2026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SOTALOL HYDROCHLORIDE
SotalolSOTALOL HYDROCHLORIDEBryant Ranch Prepack282b48b2-f9ff-474a-b01e-68a9ce5edf072026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SOTALOL HYDROCHLORIDE
SotalolSOTALOL HYDROCHLORIDEBryant Ranch Prepack51cebe16-4496-4f49-b2db-b7b21c08fa232026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SOTALOL HYDROCHLORIDE
SotalolSOTALOL HYDROCHLORIDEBryant Ranch Prepack5962c4ee-c8f7-4e38-ab8c-4848c76443622026-03-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SOTALOL HYDROCHLORIDE
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack667fc1f2-6ccf-4373-89d8-6a064ee7509e2026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sotalol Hydrochloride
generic name: SOTALOL HYDROCHLORIDE
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEAvPAKbcbc1624-283e-732f-e053-2995a90a8f112026-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sotalol Hydrochloride
generic name: SOTALOL HYDROCHLORIDE
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEProficient Rx LP10b7b81d-9ce7-4025-8559-fdfa41c8b1462026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sotalol Hydrochloride
generic name: SOTALOL HYDROCHLORIDE
Sotalol HydrochlorideSOTALOL HYDROCHLORIDENorthwind Health Company, LLCfe82c866-03d4-e07b-e053-6394a90a8b1e2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sotalol Hydrochloride
generic name: SOTALOL HYDROCHLORIDE
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEMajor Pharmaceuticals866e5717-3de2-4f19-b7c7-2275caeef78b2025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sotalol Hydrochloride
generic name: SOTALOL HYDROCHLORIDE
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEA-S Medication Solutionsbbeaba9f-0513-4980-bc29-7f9259a53ecc2025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sotalol Hydrochloride
generic name: SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDEBryant Ranch Prepack44d0ce4c-de00-4151-ad7f-48a59040a9b02025-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SOTALOL HYDROCHLORIDE
generic name: SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDEBryant Ranch Prepack56dd490f-4d78-447c-a460-f55587e8a7642025-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SOTALOL HYDROCHLORIDE
generic name: SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDEBryant Ranch Prepack14ee4756-52f2-4bbf-bd79-663839ecb1c52025-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SOTALOL HYDROCHLORIDE
generic name: SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDEBryant Ranch Prepackdb9b0b36-4c00-45b6-a50a-e08d7c61a17c2025-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: SOTALOL HYDROCHLORIDE
generic name: SOTALOL HYDROCHLORIDE
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepackd6c8f659-1c32-4431-bdb2-3211a1c810062025-11-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sotalol Hydrochloride
generic name: SOTALOL HYDROCHLORIDE
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepackbc35a3e8-681c-4fe8-96cd-b2a62f024c4b2025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sotalol Hydrochloride
generic name: SOTALOL HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.