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 3 of 4 · 67 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEA-S Medication Solutionse6836a01-220d-4b69-9b4a-c919daeb6ece2025-11-20Warnings, Adverse reactionsExact identifier
rxcui: 896762
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack0dcd514d-bda8-484b-8cf1-f5656aaab9ce2025-10-29Warnings, Adverse reactionsExact identifier
rxcui: 896762
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack20c26652-52da-4eef-8486-f91eb30e9ff72025-10-29Warnings, Adverse reactionsExact identifier
rxcui: 896762
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackdafa7411-2857-4f5a-a587-4367cfbe2bfa2025-10-23Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMacleods Pharmaceuticals Limited366134cd-6244-45fc-99f1-0193a0221b3a2025-10-06Warnings, Adverse reactionsExact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
Labetalol HydrochlorideLABETALOL HYDROCHLORIDERedPharm Drug1e1b7355-4802-d277-e063-6394a90aef442025-07-29Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENuCare Pharmaceuticals , Inc.3aff731f-1eec-19b5-e063-6294a90a31432025-07-28Warnings, Adverse reactionsExact identifier
rxcui: 896762
Labetalol HCLLABETALOL HYDROCHLORIDEA-S Medication Solutions312dde0d-5147-483e-968f-4e0d461141762025-06-19Warnings, Adverse reactionsExact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutions5faacbcc-f88f-42f7-8702-791ee82c4d182025-01-09Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEAmerican Health Packaging3004aa59-288c-4971-b77b-78789715ef5a2024-12-30Warnings, Adverse reactionsExact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEZydus Lifesciences Limiteda3c0cc1e-1c01-4009-afdc-d35a66546aec2024-11-30Exact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack64cd636d-8b48-4f29-b41d-4a048335793e2024-11-20Warnings, Adverse reactionsExact identifier
rxcui: 896762
Labetalol HydrochlorideLABETALOLMarlex Pharmaceuticals Inc28c91727-e5a8-48b3-a4df-d7bec8feda402024-10-07Warnings, Adverse reactionsExact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack94abdd54-a8e2-4858-8183-6c5d04dbceb52024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack1fce27dd-90a6-45cf-9bd7-13147d3cc0d72024-08-12Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack706a877b-c388-43e7-b083-518111b288b02024-08-06Warnings, Adverse reactionsExact identifier
rxcui: 896762
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs30280d40-28df-4c88-93bd-357a7c5289062024-06-21Warnings, Adverse reactionsExact identifier
rxcui: 896758
rxcui: 896762
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack5a39bb96-4a60-49e8-859c-16bda0fe18e42024-06-05Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack143ae21e-c350-4c92-b318-7537f4e465962024-04-08Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol hydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutions83a6e770-207a-46bc-992d-c1ad90d1006d2023-10-30Warnings, Adverse reactionsExact identifier
rxcui: 896762

Reported adverse events (FAERS/openFDA)#

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