FDA.reportPublic FDA data

NDC 53489-355 - Labetalol 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
53489-355
Package NDCs from labels
53489-355-07, 53489-355-06, 53489-355-01, 53489-355-03, 53489-355-05, 53489-355-10
Manufacturer
Mutual Pharmaceutical Company, Inc.
Effective date
2007-01-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LABETALOL HYDROCHLORIDE TABLETS, USPMutual Pharmaceutical Company, Inc.2007-01-03HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-355-01Labetalol Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
53489-355-03Labetalol Hydrochloride250 in 1 BOTTLE, PLASTICTABLET, FILM COATED2501
53489-355-05Labetalol Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5001
53489-355-06Labetalol Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
53489-355-07Labetalol Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
53489-355-10Labetalol Hydrochloride1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-355LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]16 package rows20070111_B1E6C7AB-EEFE-4089-B403-EDEAAB4F6E36.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Labetalol HydrochlorideACTIVE INGREDIENT1GEV3BAW9JLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
LabetalolACTIVE MOIETYR5H8897N95LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
Anhydrous lactoseINACTIVE INGREDIENTLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
carnauba waxINACTIVE INGREDIENTLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
FD&C Blue #2 aluminum lakeINACTIVE INGREDIENTLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
hydroxypropyl methylcelluloseINACTIVE INGREDIENTLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
magnesium stearateINACTIVE INGREDIENT70097M6I30LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
polydextroseINACTIVE INGREDIENTLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
polyethylene glycolINACTIVE INGREDIENTLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
polysorbate 80INACTIVE INGREDIENTLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
pregelatinized starch (corn)INACTIVE INGREDIENTLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
synthetic red iron oxideINACTIVE INGREDIENTLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
synthetic yellow iron oxideINACTIVE INGREDIENTLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, INC. ]1
triacetinINACTIVE INGREDIENTXHX3C3X673LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE) TABLET, FILM COATED [MUTUAL PHARMACEUTICAL COMPANY, 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 4 of 4 · 67 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEA-S Medication Solutions1a71964e-e6fa-443e-bfdd-f8852f8cf29e2023-10-26Warnings, Adverse reactionsExact identifier
rxcui: 896762
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEA-S Medication Solutionsc586ab65-56e8-4a4f-b471-902198d3e58c2023-10-17Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECadila Pharmaceuticals Limited5fba93fc-4580-48c2-a1ec-5d446680adcf2022-12-09Warnings, Adverse reactionsExact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
Labetalol hydrochlorideLABETALOL HYDROCHLORIDEProficient Rx LPc0301841-e209-4242-bace-58a20e6dd01b2022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEEpic Pharma, LLCb950655d-a9f8-4ace-bb56-0c7abbca231e2021-09-30Warnings, Adverse reactionsExact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
Labetalol hydrochlorideLABETALOL HYDROCHLORIDEActavis Pharma, Inc.a5b65a9b-6b8a-48a4-9c72-0e605bb309eb2015-12-01Warnings, Adverse reactionsExact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
B1E6C7AB-EEFE-4089-B403-EDEAAB4F6E36B1E6C7AB-EEFE-4089-B403-EDEAAB4F6E362007-01-03Warnings, Adverse reactionsExact identifier
spl id: B1E6C7AB-EEFE-4089-B403-EDEAAB4F6E36
spl set id: B1E6C7AB-EEFE-4089-B403-EDEAAB4F6E36

Reported adverse events (FAERS/openFDA)#

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