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 4 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEFosun Pharma USA Inc.4a5ffab2-a3b8-411e-992d-7f38d508643a2024-05-16Warnings, Adverse reactionsExact identifier
rxcui: 896771
unii: 1GEV3BAW9J
Labetalol hydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutionsa007d945-417c-4647-ab03-95ca219d7d382024-05-01Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
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
application number: ANDA075303
ndc (package): 51662-1602-9
ndc (package): 51662-1602-1
ndc (product): 51662-1602
ndc11 (package): 51662160201
rxcui: 896771
spl id: ea035948-1a97-5d6e-e053-2995a90a3e7b
spl set id: e76c4b37-4a34-249d-e053-2995a90aa9be
unii: 1GEV3BAW9J
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
labetalol hydrochlorideLABETALOL HYDROCHLORIDESagent Pharmaceuticalsda8af6c2-d822-4ae5-9c2d-a1d161bdefd02022-04-12Warnings, Adverse reactionsExact identifier
rxcui: 896771
unii: 1GEV3BAW9J
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: 7FLD91C86K
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: 7FLD91C86K
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEEpic Pharma, LLCb950655d-a9f8-4ace-bb56-0c7abbca231e2021-09-30Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J

Reported adverse events (FAERS/openFDA)#

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