FDA.reportPublic FDA data

NDC 51662-1602-01 - LABETALOL HCl

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
51662-1602
Requested NDC
51662-1602-01
Package NDCs from labels
51662-1602-1, 51662-1602-9, 51662-1602-01
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2022-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LABETALOL HCl - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2022-10-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1602-1LABETALOL HCl1 in 1 BOX, UNIT-DOSEINJECTION12
51662-1602-1LABETALOL HCl20 mL in 1 VIALINJECTION202
51662-1602-9LABETALOL HCl20 mL in 1 VIALINJECTION202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1602LABETALOL HCL INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 3 package rows20221002_e76c4b37-4a34-249d-e053-2995a90aa9be.zip

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 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEAdvagen Pharma Ltd1c680447-b43a-4ff1-bc64-2c2174ca1c9a2026-04-02Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsd4364caf-46c6-4144-9ba5-2c561e4f3a952026-03-26Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsd207396a-068e-4229-88cc-a1a4df7aeff22026-03-07Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsb4a5f170-a400-4986-8c64-f55d0413f0f62026-03-07Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.bf84ebae-3c91-4448-b1db-8e5ed30538662026-03-05Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMajor Pharmaceuticals35b5fd32-581d-427b-9a13-b7a02846d21d2026-03-03Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECivica, Inc.d7c53b1c-b6a5-482a-a7c8-7425d9cd9ef82026-03-03Warnings, Adverse reactionsExact identifier
application number: ANDA075303
rxcui: 896771
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEZydus Pharmaceuticals USA Inc.5942a5a8-c3c1-4ecb-921e-9bc92393bdf82026-03-02Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.ed0188ba-3fd3-4680-a829-ba242a115fab2026-02-25Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBiocon Pharma Inc.27e4ab03-c17b-4268-912c-e45a5e8f8dd82026-02-19Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Cell Energy Performance Drops 2048CELL ENERGY PERFORMANCE DROPSProfessional Complementary Health Formulas8701ea61-5d5f-466b-8d2c-f808e7b4d8fe2026-01-08WarningsExact identifier
unii: 5SL0G7R0OK
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENorthwind Health Company, LLCfaf7a1ff-f18a-8ca7-e053-6394a90a1b1f2026-01-01Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEInnogenix, Inc.82fc2d64-0572-4a9b-94fc-f6eb8d930c542025-12-23Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.99a715a0-4579-410c-b102-7ef6fab8db552025-12-19Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDERedpharm Drug32525ed4-3cca-2b99-e063-6294a90a6c662025-12-13Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEChartwell RX, LLCac439c08-1e47-4306-8308-b31d7a1a443c2025-12-02Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMullan Pharmaceutical Inc.fb5ef3ba-0a7e-4f41-9547-d734983da0d32025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 896771
unii: 1GEV3BAW9J
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEA-S Medication Solutionse6836a01-220d-4b69-9b4a-c919daeb6ece2025-11-20Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackdafa7411-2857-4f5a-a587-4367cfbe2bfa2025-10-23Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEAmneal Pharmaceuticals LLCdbf1e4c7-7c0c-4f2f-8cad-96bc6b800cfc2025-10-06Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J

Reported adverse events (FAERS/openFDA)#

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