FDA.reportPublic FDA data

labetalol hydrochloride 300 MG Oral Tablet

RxCUI
896766
RxNorm name
labetalol hydrochloride 300 MG Oral Tablet
Display name
labetalol hydrochloride 300 MG Oral Tablet
Full name
labetalol hydrochloride 300 MG Oral Tablet
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:28

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 2 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMacleods Pharmaceuticals Limited366134cd-6244-45fc-99f1-0193a0221b3a2025-10-06Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol HydrochlorideLABETALOL HYDROCHLORIDERedPharm Drug1e1b7355-4802-d277-e063-6394a90aef442025-07-29Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol HCLLABETALOL HYDROCHLORIDEA-S Medication Solutions312dde0d-5147-483e-968f-4e0d461141762025-06-19Warnings, Adverse reactionsExact identifier
rxcui: 896766
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
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEZydus Lifesciences Limiteda3c0cc1e-1c01-4009-afdc-d35a66546aec2024-11-30Exact identifier
rxcui: 896766
Labetalol HydrochlorideLABETALOLMarlex Pharmaceuticals Inc28c91727-e5a8-48b3-a4df-d7bec8feda402024-10-07Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack94abdd54-a8e2-4858-8183-6c5d04dbceb52024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepack5a39bb96-4a60-49e8-859c-16bda0fe18e42024-06-05Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECadila Pharmaceuticals Limited5fba93fc-4580-48c2-a1ec-5d446680adcf2022-12-09Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEEpic Pharma, LLCb950655d-a9f8-4ace-bb56-0c7abbca231e2021-09-30Warnings, Adverse reactionsExact identifier
rxcui: 896766
Labetalol hydrochlorideLABETALOL HYDROCHLORIDEActavis Pharma, Inc.a5b65a9b-6b8a-48a4-9c72-0e605bb309eb2015-12-01Warnings, Adverse reactionsExact identifier
rxcui: 896766

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 1 of 2 · 43 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
f7f7fade-98a6-4741-bfb9-f1eb54ad4565labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]2107These 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: 198420260325
5a39bb96-4a60-49e8-859c-16bda0fe18e4labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]2107Labetalol HCl Tablets20240605
94abdd54-a8e2-4858-8183-6c5d04dbceb5labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]2105Labetalol HCl Tablets20240820
0db22a64-1863-4188-850b-273ea746e327labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]2103Labetalol HCl Tablets20260209
b25c0287-1709-4859-93b4-4ea18801d19flabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]2102Labetalol Hydrochloride Tablets20230302
ecb357ea-ba26-4d8a-b10a-5110f777414blabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]2102Labetalol Hydrochloride Tablets20230302
312dde0d-5147-483e-968f-4e0d46114176labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]245Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only20250619
a5b65a9b-6b8a-48a4-9c72-0e605bb309eblabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]216Labetalol Hydrochloride Tablets, USP Revised : December 2015 Rx Only20151201
733d6e32-ac90-4796-bf25-9d5887c897a5labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]211These 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: 198420251223
82fc2d64-0572-4a9b-94fc-f6eb8d930c54labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]27These 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: 198420251223
bf84ebae-3c91-4448-b1db-8e5ed3053866labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]26Labetalol Hydrochloride Tablets, USP Rx only20260305
35b5fd32-581d-427b-9a13-b7a02846d21dlabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]26LABETALOL HYDROCHLORIDE TABLETS USP Rx only20260303
27e4ab03-c17b-4268-912c-e45a5e8f8dd8labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]26LABETALOL HYDROCHLORIDE TABLETS USP Rx only20260219
3004aa59-288c-4971-b77b-78789715ef5alabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]26Labetalol Hydrochloride Tablets, USP 8443901/0823 Rx only20241230
a3c0cc1e-1c01-4009-afdc-d35a66546aeclabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]26Labetalol Hydrochloride Tablets, USP Rx only20241130
06ff81fe-9226-49a7-aa5c-f52b059d7cablabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]26Labetalol Hydrochloride Tablets, USP 100 mg, 200 mg and 300 mg Rx only20241007
5942a5a8-c3c1-4ecb-921e-9bc92393bdf8labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]25Labetalol Hydrochloride Tablets, USP Rx only20260302
28c91727-e5a8-48b3-a4df-d7bec8feda40labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]25Labetalol Hydrochloride Tablets20241007
5fba93fc-4580-48c2-a1ec-5d446680adcflabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]25Labetalol Hydrochloride Tablets, USP Rx only20221209
d3ca153c-25b2-4506-91bd-bf9d6a4c01felabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]24LABETALOL HYDROCHLORIDE TABLETS USP Rx only20260519
d5ce687f-4a37-d3e6-e053-2995a90aa974labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]24LABETALOL HYDROCHLORIDE TABLETS USP Rx only20260416
1c680447-b43a-4ff1-bc64-2c2174ca1c9alabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]24Labetalol Hydrochloride Tablets USP Rx only20260402
ed0188ba-3fd3-4680-a829-ba242a115fablabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]24Labetalol Hydrochloride Tablets, USP Rx only20260225
a4195473-51a9-40f1-8678-1478ebca2d84labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]24TRANDATE ® (labetalol hydrochloride) Tablets20091214
d4364caf-46c6-4144-9ba5-2c561e4f3a95labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]23LABETALOL HYDROCHLORIDE TABLETS USP Rx only20260326
ac439c08-1e47-4306-8308-b31d7a1a443clabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]23Labetalol Hydrochloride Tablets, USP Rx only20251202
5faacbcc-f88f-42f7-8702-791ee82c4d18labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]23Labetalol Hydrochloride Tablets, USP Rx only20250109
63ede355-42ec-4c52-a941-51e5f6b35ed6labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]23Labetalol Hydrochloride Tablets, USP Rx only20230704
e2848ca6-ad8c-4e03-a2b9-12b1d0231135labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]23Labetalol Hydrochloride Tablets20210614
01735685-40e0-4323-af5a-91db399f6451labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]2320120402
5bd81a8a-a480-4c8d-bd4f-3158412e6a73labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]22Labetalol Hydrochloride Tablets, USP Rx only20260413
106a0959-5830-489f-ba60-afd4eb0fac36labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]22Labetalol Hydrochloride Tablets USP Rx only20260402
e4562c70-f245-4dbe-8fe1-0bb64a91a315labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]22Labetalol Hydrochloride Tablets, USP Rx only20260320
dafa7411-2857-4f5a-a587-4367cfbe2bfalabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]22LABETALOL HYDROCHLORIDE TABLETS USP Rx only20251023
1e1b7355-4802-d277-e063-6394a90aef44labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]22LABETALOL HYDROCHLORIDE TABLETS USP Rx only20250729
366134cd-6244-45fc-99f1-0193a0221b3alabetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 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
266e3af5-edd9-5854-e063-6294a90ae113labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]21Labetalol Hydrochloride Tablets USP Rx only20241108
88ff4e25-bef7-4a8b-a292-23878baac116labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]21Labetalol Hydrochloride Tablets USP Revised : July 2008 Rx only 200062320110921
7b09b29d-095d-4bf3-b991-8123c14d7a00labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]2120110901
b1e6c7ab-eefe-4089-b403-edeaab4f6e36labetalol HCl 300 MG Oral Tablet [PSN] · labetalol hydrochloride 300 MG Oral Tablet [SCD]21LABETALOL HYDROCHLORIDE TABLETS, USP20070103