FDA.reportPublic FDA data

NDC 65219-642-01 - Dexmedetomidine 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
65219-642
Requested NDC
65219-642-01
Package NDCs from labels
65219-642-01, 65219-642-02
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2026-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexmedetomidine Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2026-01-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-642-01Dexmedetomidine Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION21
65219-642-02Dexmedetomidine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION251

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 35 of 46 · 911 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 4550K0SC9B
Altachlore Sodium Chloride HypertonicitySODIUM CHLORIDEAltaire Pharmaceuticals Inc.dc0d94d8-4475-4956-8ded-bdb9496074e42023-12-09WarningsExact identifier
unii: 451W47IQ8X
terrasil Eczema and Psoriasis Severe OutbreakGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions4d7128fb-57f1-4d0d-a83a-daef40928ecd2023-11-30WarningsExact identifier
unii: 451W47IQ8X
terragen HG Formula Maximum StrengthGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse632c831-e25d-4d04-ba72-2327d25713b12023-11-30WarningsExact identifier
unii: 451W47IQ8X
Femstat CECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.420119ca-f2bf-40e3-9e40-00498724c2282023-11-30WarningsExact identifier
unii: 451W47IQ8X
EndoparGLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, OOPHORINUM (SUIS), ORCHITINUM (BOVINE), PINEAL GLAND, THYROIDINUM, ARSENICUM ALBUM, BARYTA CARBONICA, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PULSATILLA (PRATENSIS)Energique, Inc.06375c3e-cc05-4450-9117-1d3dc72636eb2023-11-21WarningsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8646d7ea-cf5e-607d-e053-2a91aa0aeca12023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86466121-7217-d053-e053-2a91aa0a8f8a2023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron864669c9-5bdc-232f-e053-2a91aa0a1fc62023-11-14Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86462e06-d221-36b7-e053-2991aa0a1d822023-11-14Exact identifier
unii: 451W47IQ8X
Mineffect nasal mistCALCAREA SILICATA, SILICEA, SULPHUR, NATRUM MURIATICUM, FERRUM METALLICUM, FERRUM PHOSPHORICUM, PHOSPHORUS, FERRUM MURIATICUM, TITANIUM METALLICUM,Kadesh Incoporation Co,Ltd3a29bf95-a8a3-4517-aedf-0cd4a91b349c2023-10-31WarningsExact identifier
unii: 451W47IQ8X
InsomniaAQUILEGIA VULGARIS, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, HUMULUS LUPULUS, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, MELATONIN, MELISSA OFFICINALIS, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISLiddell Laboratories, Inc.18c15f17-1a16-4595-9d23-20353363cd722023-10-31WarningsExact identifier
unii: 451W47IQ8X
SalineNASALGERI-CARE PHARMACEUTICAL CORPd293cc13-4043-0d58-e053-2995a90a3fbc2023-10-24WarningsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8644ffef-f0ec-5c06-e053-2a91aa0ae83d2023-10-23Exact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron6a212a52-32be-21b8-e053-2991aa0aea2f2023-10-22Exact identifier
unii: 451W47IQ8X
HPYL PLUSANGELICA ARCHANGELICA, GERANIUM MACULATUM, HYDRASTIS CANADENSIS, SINAPIS NIGRA, SYMPHYTUM OFFICINALE, RATANHIA, ACETICUM ACIDUM, CARBOLICUM ACIDUM, ORNITHOGALUM UMBELLATUM, ABIES CANADENSIS, ANACARDIUM ORIENTALE, BISMUTHUM SUBNITRICUM, CONDURANGO, GRAPHITES, IRIS VERSICOLOR, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MEZEREUM, EUPHORBIUM OFFICINARUM, NUX VOMICADeseret Biologicals, Inc.c90278bf-b08a-4c79-86c0-dafd3b7756c62023-10-12WarningsExact identifier
unii: Q40Q9N063P
MetabCALCAREA SULPHURICA, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, CEREBELLUM (SUIS), GALLBLADDER (BOVINE), HEART (BOVINE), HEPAR (BOVINE), HYPOTHALAMUS SUIS, INTESTINE (SUIS), KIDNEY (BOVINE), LUNG (BOVINE), MEDULLA OSSIS SUIS, PANCREAS SUIS, PINEAL GLAND (SUIS), RECTAL MUCOSA (SUIS), SPLEEN (BOVINE), STOMACH (SUIS), THYMUS (OVINE), THYROIDINUM (BOVINE), URINARY BLADDER (SUIS), PITUITARUM POSTERIUM (BOVINE), ACETYL COENZYME A,Nutritional Specialties, Inc.bbed9973-238f-47c5-9a50-ac0869a7eb3a2023-10-09WarningsExact identifier
unii: 451W47IQ8X
Dexmedetomidine Hydrochloride in 0.9% Sodium ChlorideDEXMEDETOMIDINE HYDROCHLORIDESagent Pharmaceuticalsa99335d0-1e87-4180-bde3-cbb12bf91a522023-10-06Warnings, Adverse reactionsExact identifier
unii: 1018WH7F9I
Isolyte S pH 7.4SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATEB. Braun Medical Inc.150437b6-320e-4c69-a434-2a26a1f0b2e42023-10-06Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: 4550K0SC9B
BHI MigraineACETIC ACID, ARANEUS DIADEMATUS, ASAFETIDA, BRYONIA ALBA WHOLE, TRIBASIC CALCIUM PHOSPHATE, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, MARSDENIA CONDURANGO BARK, TUBOCURARINE CHLORIDE, KALMIA LATIFOLIA LEAF, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, AND SILICON DIOXIDEMediNatura Inc11cad8ba-6914-420e-bab0-4ca37d33f2e62023-09-28WarningsExact identifier
unii: Q40Q9N063P

Reported adverse events (FAERS/openFDA)#

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