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 4 of 10 · 185 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMullan Pharmaceutical Inc.fb5ef3ba-0a7e-4f41-9547-d734983da0d32025-12-01Warnings, Adverse reactionsExact identifier
rxcui: 896771
unii: 1GEV3BAW9J
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: XF417D3PSL
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEA-S Medication Solutionse6836a01-220d-4b69-9b4a-c919daeb6ece2025-11-20Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATER J General Corporationdbb0d067-71f0-45e4-bc98-548cf4a90b3a2025-11-17WarningsExact identifier
unii: XF417D3PSL
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEBryant Ranch Prepackdafa7411-2857-4f5a-a587-4367cfbe2bfa2025-10-23Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
unii: XF417D3PSL
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDEAmneal Pharmaceuticals LLCdbf1e4c7-7c0c-4f2f-8cad-96bc6b800cfc2025-10-06Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Mitochondria PROARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: XF417D3PSL
Labetalol HydrochlorideLABETALOL HYDROCHLORIDEMacleods Pharmaceuticals Limited366134cd-6244-45fc-99f1-0193a0221b3a2025-10-06Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.121eb51a-befe-47ea-85c6-d77e8c7e58642025-10-06WarningsExact identifier
unii: XF417D3PSL
Labetalol HydrochlorideLABETALOL HYDROCHLORIDERedPharm Drug1e1b7355-4802-d277-e063-6394a90aef442025-07-29Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Labetalol HydrochlorideLABETALOL HYDROCHLORIDENuCare Pharmaceuticals , Inc.3aff731f-1eec-19b5-e063-6294a90a31432025-07-28Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: XF417D3PSL
EndocrinpathALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corporation70f84941-b8a1-48f4-9c05-554e554f00492025-07-11WarningsExact identifier
unii: XF417D3PSL
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEBelleview Biosciences LLC3245e0e5-5e7f-c3f7-e063-6394a90ac2582025-07-07Adverse reactionsExact identifier
unii: XF417D3PSL
Labetalol HCLLABETALOL HYDROCHLORIDEA-S Medication Solutions312dde0d-5147-483e-968f-4e0d461141762025-06-19Warnings, Adverse reactionsExact identifier
unii: 1GEV3BAW9J
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 5SL0G7R0OK
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, 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, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: Z8IX2SC1OH
unii: A2I8C7HI9T
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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