FDA.reportPublic FDA data

NDC 53489-291 - 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
53489-291
Package NDCs from labels
53489-291-02, 53489-291-01, 53489-291-03, 53489-291-05, 53489-291-10
Manufacturer
MUTUAL PHARMACEUTICAL CO., INC.
Effective date
2006-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SOTALOL HYDROCHLORIDE TABLETSMUTUAL PHARMACEUTICAL CO., INC.2006-12-01HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-291-01SOTALOL HYDROCHLORIDE100 in 1 BOTTLE, PLASTICTABLET1001
53489-291-02SOTALOL HYDROCHLORIDE50 in 1 BOTTLE, PLASTICTABLET501
53489-291-03SOTALOL HYDROCHLORIDE250 in 1 BOTTLE, PLASTICTABLET2501
53489-291-05SOTALOL HYDROCHLORIDE500 in 1 BOTTLE, PLASTICTABLET5001
53489-291-10SOTALOL HYDROCHLORIDE1000 in 1 BOTTLE, PLASTICTABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-291SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]15 package rows20061208_62A71C8C-D92D-4122-848F-9AE35F8BBE2B.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sotalol hydrochlorideACTIVE INGREDIENTHEC37C70XXSOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]1
sotalolACTIVE MOIETYA6D97U294ISOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]1
Anhydrous lactoseINACTIVE INGREDIENTSOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]1
collloidal silicon dioxideINACTIVE INGREDIENTSOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]1
corn starchINACTIVE INGREDIENTSOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]1
FD&C Blue #2 Aluminum LakeINACTIVE INGREDIENTSOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]1
microcrystalline celluloseINACTIVE INGREDIENTSOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]1
pregelatinized starchINACTIVE INGREDIENTSOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]1
sodium starch glycolateINACTIVE INGREDIENTSOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APSOTALOL HYDROCHLORIDE (SOTALOL HYDROCHLORIDE) TABLET [MUTUAL PHARMACEUTICAL CO., INC.]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 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
62A71C8C-D92D-4122-848F-9AE35F8BBE2B62A71C8C-D92D-4122-848F-9AE35F8BBE2B2006-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 62A71C8C-D92D-4122-848F-9AE35F8BBE2B
spl set id: 62A71C8C-D92D-4122-848F-9AE35F8BBE2B

Reported adverse events (FAERS/openFDA)#

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