FDA.reportPublic FDA data

NDC 68084-654-11 - Sotalol Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68084-654
Requested NDC
68084-654-11
Package NDCs from labels
68084-654-11, 68084-654-01
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-10-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sotalol Hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2026-10-06HUMAN PRESCRIPTION DRUG LABEL
Sotalol Hydrochloride - American Health PackagingAmerican Health Packaging2026-05-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-654-01Sotalol Hydrochloride100 in 1 BOX, UNIT-DOSETABLET1009
68084-654-11Sotalol Hydrochloride1 in 1 BLISTER PACKTABLET19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-654SOTALOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20240522_4614480b-b36e-4dbd-9fc0-d083890d297d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-654-01EA - Each68084-6545e6677c9-1e8f-42c4-96a1-5be04a9ab4fb12014-04-03
68084-654-11EA - Each68084-654ba89d6d0-3127-4f5c-86e7-e8a38dda7e4d12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOTALOL HYDROCHLORIDEACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1
SOTALOLACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOTALOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOTALOL HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1

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 3 of 3 · 47 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sotalol HydrochlorideSOTALOL HYDROCHLORIDETeva Pharmaceuticals USA, Inc.8e2772cb-7dea-42d1-ba31-d479ba7cb09a2023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack2f13a6dd-dd77-47c8-ac5d-4a746c32dbd02023-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEOxford Pharmaceuticals, LLCc8ac6351-b1e9-4dd2-82f2-5980814fda152023-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5e005309-4eca-4536-8743-c6ed9e5b31952023-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076140
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEProficient Rx LP517824b1-11be-40a9-9066-d1a6a32a29382023-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076140
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC253da1e1-022a-4175-bd7f-e7673cba07672022-02-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC5ede17b7-3898-4f9f-abec-e15620cef76a2018-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HEC37C70XX

Reported adverse events (FAERS/openFDA)#

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