FDA.reportPublic FDA data

NDC 50268-725-11 - 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
50268-725
Requested NDC
50268-725-11
Package NDCs from labels
50268-725-11, 50268-725-15
Manufacturer
AvPAK
Effective date
2026-01-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sotalol Hydrochloride - AvPAKAvPAK2026-01-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-725-11Sotalol Hydrochloride1 in 1 BLISTER PACKTABLET13
50268-725-15Sotalol Hydrochloride50 in 1 BOXTABLET503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-725SOTALOL HYDROCHLORIDE TABLET [AVPAK]2Current NDC, Legacy NDC, 2 package rows20221116_bcbc1624-283e-732f-e053-2995a90a8f11.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-725-11EA - Each50268-725835612c6-92b8-4a46-920c-3274d87f5c4b12021-04-08
50268-725-15EA - Each50268-725fbcae383-9e0f-407a-928f-7b5250356fc112021-04-08

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
rxcui: 1923422
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
rxcui: 1923426
unii: HEC37C70XX
SotalolSOTALOL HYDROCHLORIDEUNICHEM PHARMACEUTICALS (USA), INC.56879738-8662-4f5c-8386-761ab2b5e46f2026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923422
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
rxcui: 1923422
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
ndc (package): 50268-725-15
ndc (package): 50268-725-11
ndc (package): 50268-724-11
ndc (package): 50268-724-15
ndc (product): 50268-724
ndc (product): 50268-725
ndc11 (package): 50268072511
rxcui: 1923422
rxcui: 1923426
spl id: 47fc0908-1c7a-abc6-e063-6294a90a20b2
spl set id: bcbc1624-283e-732f-e053-2995a90a8f11
unii: HEC37C70XX
Sotalol HydrochlorideSOTALOL HYDROCHLORIDEProficient Rx LP10b7b81d-9ce7-4025-8559-fdfa41c8b1462026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1923422
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
rxcui: 1923422
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
rxcui: 1923426
unii: HEC37C70XX

Reported adverse events (FAERS/openFDA)#

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