FDA.reportPublic FDA data

labetalol hydrochloride 100 MG Oral Tablet

RxCUI
896758
RxNorm name
labetalol hydrochloride 100 MG Oral Tablet
Display name
labetalol hydrochloride 100 MG Oral Tablet
Full name
labetalol hydrochloride 100 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECardinal Health 107, LLC63db5b00-e864-4b2d-84f2-00bf35211b9b2026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEREMEDYREPACK INC.e2e50571-d8c1-43e7-b90f-877ba1c35c9b2026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECoupler LLC5954cc5c-3e73-e039-e063-6394a90a7d6a2026-08-18Warnings, Adverse reactionsExact identifier
rxcui: 896758
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDESt. Mary's Medical Park Pharmacyed2293f8-2b82-c3db-e053-2995a90ad46c2026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBluePoint Laboratories Inc.63ede355-42ec-4c52-a941-51e5f6b35ed62026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBluePoint Laboratoriese4562c70-f245-4dbe-8fe1-0bb64a91a3152026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECardinal Health 107, LLCd3ca153c-25b2-4506-91bd-bf9d6a4c01fe2026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackc0c1a162-cd30-4ac9-bc62-407493ed54a52026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEProficient Rx LP54b75509-824b-4291-818d-71dc1b88915f2026-05-01Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEGolden State Medical Supply, Inc.d5ce687f-4a37-d3e6-e053-2995a90aa9742026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENorthStar Rx LLC5bd81a8a-a480-4c8d-bd4f-3158412e6a732026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 896758
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEREMEDYREPACK INC.ae5d7b3b-e444-48d3-9d85-9b07319f93742026-04-10Warnings, Adverse reactionsExact identifier
rxcui: 896758
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEAdvagen Pharma Ltd1c680447-b43a-4ff1-bc64-2c2174ca1c9a2026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack35e7bce0-d9ff-4f8b-95c5-218da2a2d9292026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsd207396a-068e-4229-88cc-a1a4df7aeff22026-03-07Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsb4a5f170-a400-4986-8c64-f55d0413f0f62026-03-07Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.bf84ebae-3c91-4448-b1db-8e5ed30538662026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMajor Pharmaceuticals35b5fd32-581d-427b-9a13-b7a02846d21d2026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEZydus Pharmaceuticals USA Inc.5942a5a8-c3c1-4ecb-921e-9bc92393bdf82026-03-02Warnings, Adverse reactionsExact identifier
rxcui: 896758
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.ed0188ba-3fd3-4680-a829-ba242a115fab2026-02-25Warnings, Adverse reactionsExact identifier
rxcui: 896758

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 2 of 2 · 49 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
54b75509-824b-4291-818d-71dc1b88915flabetalol HCl 100 MG Oral Tablet [PSN] · labetalol hydrochloride 100 MG Oral Tablet [SCD]21LABETALOL HYDROCHLORIDE TABLETS USP Rx only20260501
d8b69cc9-bdee-4e24-a3d8-d1887de5a17dlabetalol HCl 100 MG Oral Tablet [PSN] · labetalol hydrochloride 100 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use LABETALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LABETALOL HYDROCHLORIDE TABLETS. LABETALOL HYDROCHLORIDE tablets, for oral use. Initial U.S. Approval: 198420260206
366134cd-6244-45fc-99f1-0193a0221b3alabetalol HCl 100 MG Oral Tablet [PSN] · labetalol hydrochloride 100 MG Oral Tablet [SCD]21These highlights do not include all the information needed to use LABETALOL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for LABETALOL HYDROCHLORIDE TABLETS. LABETALOL HYDROCHLORIDE tablets, for oral use. Initial U.S. Approval: 198420251006
266dd638-6669-dfaa-e063-6294a90a4c96labetalol HCl 100 MG Oral Tablet [PSN] · labetalol hydrochloride 100 MG Oral Tablet [SCD]21Labetalol Hydrochloride Tablets, USP Rx only20241108
c586ab65-56e8-4a4f-b471-902198d3e58clabetalol HCl 100 MG Oral Tablet [PSN] · labetalol hydrochloride 100 MG Oral Tablet [SCD]21Labetalol Hydrochloride Tablets USP Rx only20231017
ed2293f8-2b82-c3db-e053-2995a90ad46clabetalol HCl 100 MG Oral Tablet [PSN] · labetalol hydrochloride 100 MG Oral Tablet [SCD]21Labetalol Hydrochloride Tablets USP Rx only20221110
b950655d-a9f8-4ace-bb56-0c7abbca231elabetalol HCl 100 MG Oral Tablet [PSN] · labetalol hydrochloride 100 MG Oral Tablet [SCD]21labetalol hydrochloride tablets, usp20210930
b4c13317-88eb-48f2-aba2-50f01c8ff938labetalol HCl 100 MG Oral Tablet [PSN] · labetalol hydrochloride 100 MG Oral Tablet [SCD]21Labetalol20180406
b1e6c7ab-eefe-4089-b403-edeaab4f6e36labetalol HCl 100 MG Oral Tablet [PSN] · labetalol hydrochloride 100 MG Oral Tablet [SCD]21LABETALOL HYDROCHLORIDE TABLETS, USP20070103