FDA.reportPublic FDA data

NDC 36000-320-01 - 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
36000-320
Requested NDC
36000-320-01
Package NDCs from labels
36000-320-01, 36000-320-10
Manufacturer
Baxter Healthcare Corporation | CAPLIN STERILES LIMITED
Effective date
2020-07-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LABETALOL - Baxter Healthcare Corporation | CAPLIN STERILES LIMITEDBaxter Healthcare Corporation | CAPLIN STERILES LIMITED2020-07-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36000-320-01Labetalol Hydrochloride4 mL in 1 VIALINJECTION, SOLUTION46
36000-320-10Labetalol Hydrochloride10 in 1 CARTONINJECTION, SOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36000-320LABETALOL HYDROCHLORIDE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5Current NDC, Legacy NDC, 2 package rows20240921_b17a7b3a-e7a5-4987-ae85-ad970e7540c7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36000-320-01ML - Milliliter36000-320b34ef2e5-e1d1-4c87-a0d3-882601c81f1a12021-05-05
36000-320-10ML - Milliliter36000-3206134708c-3a79-4938-bc35-c888ef71af6812021-05-05

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 5 of 10 · 185 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Co Enzyme PhaseACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM,Deseret Biologicals, Inc.6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db2025-04-08WarningsExact identifier
unii: XF417D3PSL
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Labetalol HydrochlorideLABETALOL HYDROCHLORIDECaplin Steriles Limited77152699-1ca8-442a-8cb4-80b0ffbec6f22025-02-14Warnings, Adverse reactionsExact identifier
rxcui: 896771
unii: 1GEV3BAW9J
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: XF417D3PSL
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEA-S Medication Solutions5faacbcc-f88f-42f7-8702-791ee82c4d182025-01-09Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEAmerican Health Packaging3004aa59-288c-4971-b77b-78789715ef5a2024-12-30Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
unii: XF417D3PSL
Alka-Seltzer Heartburn and PainANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.2928e140-c868-5bf5-e063-6394a90ab0242024-12-13WarningsExact identifier
unii: XF417D3PSL
Household DetoxALLIUM SATIVUM, ALUMINA, ANTIPYRINUM, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, DIETHYLSTILBESTROL, DIOXIN, FOLLICULINUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PETROLEUM, PHENACETINUM, PTELEA TRIFOLIATA, SODIUM CARBOXYMETHYL CELLULOSE, TEFLONDeseret Biologicals, Inc.7f79058a-c35a-429a-be3c-4cff1d6570872024-12-13WarningsExact identifier
unii: A2I8C7HI9T
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
unii: XF417D3PSL
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
unii: XF417D3PSL
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEZydus Lifesciences Limiteda3c0cc1e-1c01-4009-afdc-d35a66546aec2024-11-30Exact identifier
unii: 1GEV3BAW9J
CVS Health Extra Strength Antacid and Pain RelieverASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATECVS Pharmacyafe9e755-18ba-305f-e053-2995a90aa8d02024-11-14WarningsExact identifier
unii: XF417D3PSL
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEPharmaceutical Associates, Inc.63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd52024-11-13Adverse reactionsExact identifier
unii: XF417D3PSL
Walgreens Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreens667418fc-a3ab-cbc7-e053-2a91aa0a20232024-11-13WarningsExact identifier
unii: XF417D3PSL
Up and Up Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATETarget Corporationa72eef45-b985-638a-e053-2995a90aa20a2024-11-13WarningsExact identifier
unii: XF417D3PSL
Signature Care Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATESafeway, Inc6e120024-475a-73af-e053-2a91aa0a42a62024-11-13Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Kroger Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEKroger Company6d858b0e-a3c8-2686-e053-2991aa0acc062024-11-13WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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