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
American Health Packaging
Effective date
2026-05-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sotalol Hydrochloride - American Health PackagingAmerican Health Packaging2026-05-20HUMAN PRESCRIPTION DRUG LABEL
Sotalol Hydrochloride - Cardinal Health 107, LLCCardinal Health 107, LLC2025-11-05HUMAN 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 1 of 3 · 47 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 reactionsExact identifier
application number: ANDA076140
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack9a36d95c-6e93-4e57-befe-b5274f3592442026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HEC37C70XX
SotalolSOTALOL HYDROCHLORIDEBryant Ranch Prepackc824f6b2-80c5-45a6-a491-4c14c9f5e33d2026-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEAmerican Health Packaging4614480b-b36e-4dbd-9fc0-d083890d297d2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076140
ndc (package): 68084-654-11
ndc (package): 68084-654-01
ndc (product): 68084-654
ndc11 (package): 68084065411
rxcui: 1923426
spl id: 52434622-ecc0-73e1-e063-6294a90a0859
spl set id: 4614480b-b36e-4dbd-9fc0-d083890d297d
unii: HEC37C70XX
SotalolSOTALOL HYDROCHLORIDEUNICHEM PHARMACEUTICALS (USA), INC.56879738-8662-4f5c-8386-761ab2b5e46f2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923426
unii: HEC37C70XX
SotalolSOTALOL HYDROCHLORIDEBryant Ranch Prepack282b48b2-f9ff-474a-b01e-68a9ce5edf072026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923426
unii: HEC37C70XX
SotalolSOTALOL HYDROCHLORIDEBryant Ranch Prepack51cebe16-4496-4f49-b2db-b7b21c08fa232026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HEC37C70XX
SotalolSOTALOL HYDROCHLORIDEBryant Ranch Prepack5962c4ee-c8f7-4e38-ab8c-4848c76443622026-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepack667fc1f2-6ccf-4373-89d8-6a064ee7509e2026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEAvPAKbcbc1624-283e-732f-e053-2995a90a8f112026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076140
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEProficient Rx LP10b7b81d-9ce7-4025-8559-fdfa41c8b1462026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDENorthwind Health Company, LLCfe82c866-03d4-e07b-e053-6394a90a8b1e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076140
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEMajor Pharmaceuticals866e5717-3de2-4f19-b7c7-2275caeef78b2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076140
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEA-S Medication Solutionsbbeaba9f-0513-4980-bc29-7f9259a53ecc2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923426
unii: HEC37C70XX
SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDEBryant Ranch Prepack44d0ce4c-de00-4151-ad7f-48a59040a9b02025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923426
unii: HEC37C70XX
SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDEBryant Ranch Prepack56dd490f-4d78-447c-a460-f55587e8a7642025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HEC37C70XX
SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDEBryant Ranch Prepack14ee4756-52f2-4bbf-bd79-663839ecb1c52025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HEC37C70XX
SOTALOL HYDROCHLORIDESOTALOL HYDROCHLORIDEBryant Ranch Prepackdb9b0b36-4c00-45b6-a50a-e08d7c61a17c2025-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEBryant Ranch Prepackd6c8f659-1c32-4431-bdb2-3211a1c810062025-11-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923426
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDECardinal Health 107, LLC4f5902e1-9f9f-4c6b-817d-2efbb5e280612025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA076140
ndc (package): 55154-8179-0
ndc (product): 55154-8179
rxcui: 1923426
spl id: 860b7d5f-efce-45a9-91d9-273d318ed5c3
spl set id: 4f5902e1-9f9f-4c6b-817d-2efbb5e28061
unii: HEC37C70XX

Reported adverse events (FAERS/openFDA)#

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