FDA.reportPublic FDA data

NDC 72162-2118-01 - 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
72162-2118
Requested NDC
72162-2118-01
Package NDCs from labels
72162-2118-1, 72162-2118-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-11-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sotalol Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2025-11-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2118-1Sotalol Hydrochloride100 in 1 BOTTLETABLET100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2118SOTALOL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20241123_bc35a3e8-681c-4fe8-96cd-b2a62f024c4b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2118-1EA - Each72162-21183174036e-b1e9-48db-9ae9-9e105ade89a812023-10-16

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 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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.