FDA.reportPublic FDA data

NDC 83301-0059-01 - 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
83301-0059
Requested NDC
83301-0059-01
Package NDCs from labels
83301-0059-1, 83301-0059-01
Manufacturer
Mullan Pharmaceutical Inc. | Gland Pharma Limited
Effective date
2025-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Labetalol Hydrochloride - Mullan Pharmaceutical Inc. | Gland Pharma LimitedMullan Pharmaceutical Inc. | Gland Pharma Limited2025-12-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0059-1Labetalol Hydrochloride1 in 1 CARTONINJECTION11
83301-0059-1Labetalol Hydrochloride40 mL in 1 VIAL, MULTI-DOSEINJECTION401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0059-1ML - Milliliter83301-00593c7bf075-bb6f-4be6-bf45-f43739fc4db312026-04-20

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 6 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs30280d40-28df-4c88-93bd-357a7c5289062024-06-21Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 2968PHW8QP
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEGland Pharma Limited48caf986-3126-48e1-afcd-16d65c9cfe002024-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA090699
rxcui: 896771
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEFosun Pharma USA Inc.4a5ffab2-a3b8-411e-992d-7f38d508643a2024-05-16Warnings, Adverse reactionsExact identifier
application number: ANDA090699
rxcui: 896771
unii: 1GEV3BAW9J
Labetalol hydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsa007d945-417c-4647-ab03-95ca219d7d382024-05-01Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: 2968PHW8QP
PhexxiLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.173ff411-7227-47b0-94dc-844e1ebaf14e2023-11-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Labetalol hydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutions83a6e770-207a-46bc-992d-c1ad90d1006d2023-10-30Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEA-S Medication Solutions1a71964e-e6fa-443e-bfdd-f8852f8cf29e2023-10-26Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEA-S Medication Solutionsc586ab65-56e8-4a4f-b471-902198d3e58c2023-10-17Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: A2I8C7HI9T
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENorthStar Rx LLCa2d07ec0-3718-40eb-9d0a-79c557c486b92023-04-28Warnings, Adverse reactionsExact identifier
rxcui: 896771
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECadila Pharmaceuticals Limited5fba93fc-4580-48c2-a1ec-5d446680adcf2022-12-09Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol hydrochlorideLABETALOL HYDROCHLORIDEProficient Rx LPc0301841-e209-4242-bace-58a20e6dd01b2022-11-01Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
LABETALOL HClLABETALOL HCLHF Acquisition Co LLC, DBA HealthFirste76c4b37-4a34-249d-e053-2995a90aa9be2022-10-01Warnings, Adverse reactionsExact identifier
rxcui: 896771
unii: 1GEV3BAW9J

Reported adverse events (FAERS/openFDA)#

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