FDA.reportPublic FDA data

NDC 70518-3499-01 - 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
70518-3499
Requested NDC
70518-3499-01
Package NDCs from labels
70518-3499-0, 70518-3499-1, 70518-3499-2, 70518-3499-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Labetalol Hydrochloride Tablets USP Rx onlyREMEDYREPACK INC.2026-04-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3499-0LABETALOL HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, FILM COATED305
70518-3499-1LABETALOL HYDROCHLORIDE180 in 1 BOTTLE, PLASTICTABLET, FILM COATED1805
70518-3499-2LABETALOL HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3499LABETALOL HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 3 package rows20240116_ae5d7b3b-e444-48d3-9d85-9b07319f9374.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 14 of 112 · 2,224 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: B697894SGQ
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsd207396a-068e-4229-88cc-a1a4df7aeff22026-03-07Warnings, Adverse reactionsExact identifier
rxcui: 896758
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsb4a5f170-a400-4986-8c64-f55d0413f0f62026-03-07Warnings, Adverse reactionsExact identifier
rxcui: 896758
unii: 1GEV3BAW9J
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: B697894SGQ
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
unii: 15FIX9V2JP
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.bf84ebae-3c91-4448-b1db-8e5ed30538662026-03-05Warnings, Adverse reactionsExact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMajor Pharmaceuticals35b5fd32-581d-427b-9a13-b7a02846d21d2026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECivica, Inc.d7c53b1c-b6a5-482a-a7c8-7425d9cd9ef82026-03-03Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEZydus Pharmaceuticals USA Inc.5942a5a8-c3c1-4ecb-921e-9bc92393bdf82026-03-02Warnings, Adverse reactionsExact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
unii: 1GEV3BAW9J
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
TIBENA EVERY DAY REAL SUN BLOCKTITANIUM DIOXIDE, ZINC OXIDEKONAD CO LTD211c9930-4f91-cf8f-e063-6394a90a97b32026-02-26WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
unii: 15FIX9V2JP
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.ed0188ba-3fd3-4680-a829-ba242a115fab2026-02-25Warnings, Adverse reactionsExact identifier
rxcui: 896766
rxcui: 896758
rxcui: 896762
unii: 1GEV3BAW9J
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b943d72-dcde-e2e4-e063-6294a90ab7c42026-02-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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