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 25 of 46 · 911 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-65ARSENIC TRIOXIDE, BERBERIS AQUIFOLIUM ROOT BARK, OYSTER SHELL CALCIUM CARBONATE, CRUDE, GRAPHITE, CENTELLA ASIATICA, AND SODIUM CHLORIDEDNA Labs, Inc.94d4b66a-f995-4516-bdcf-2152c2a624dd2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-88COCCULUS INDICUS, NATRUM MURIATICUM, HELONIAS DIOICA, CALCAREA PHOSPHORICUM, IGNATIA AMARA, MAGNESIA PHOSPHORICUM, CIMICIFUGA RACEMOSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, SEPIA, KALIUM PHOSPHORICUM, ZINCUM METALLICUM, PITUITARY, ADRENAL, OVARIANDNA Labs, Inc.1eefff9c-d86c-44ef-b968-9a8c5a9c54032025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: 451W47IQ8X
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
unii: 451W47IQ8X
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a2b9456-8ca0-8253-e053-2a95a90a8f122025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a2a34f9-ed95-9921-e053-2995a90a0d592025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a2bc45d-e0c8-3af2-e053-2a95a90af0f12025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a67169d-6b15-3406-e053-2995a90a60e42025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a673225-27be-040a-e053-2a95a90a0a982025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a66b61d-82bd-2bbb-e053-2995a90a0b582025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a677063-09d2-8052-e053-2a95a90affae2025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a678fac-289c-0f5c-e053-2995a90a0f432025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a66da0b-ee7b-2b69-e053-2995a90ae9512025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a667d80-d05c-2d18-e053-2995a90a29182025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a66e2a9-a661-e847-e053-2a95a90aa3042025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a67a0bb-6943-2f5f-e053-2a95a90aac6e2025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a6711a9-e0a4-9083-e053-2a95a90ad4a42025-01-09Exact identifier
unii: Q40Q9N063P
Acidum AceticumACIDUM ACETICUMHahnemann Laboratories, Inc.9a67bb27-cb44-4a1d-e053-2a95a90a0ee22025-01-09Exact identifier
unii: Q40Q9N063P
A-36BOS TAURUS ADRENAL GLAND, AGRIMONIA EUPATORIA, BELLIS PERENNIS, CAMPHOR (NATURAL), MATRICARIA CHAMOMILLA, EQUISETUM HYEMALE, FRAXINUS AMERICANA BARK, FORMICA RUFA, HISTAMINE DIHYDROCHLORIDE, IODINE, POTASSIUM DICHROMATE, CANIS LUPUS FAMILIARIS MILK, SODIUM CHLORIDE, ANEMONE PULSATILLA, SALIX NIGRA BARK, AND TOBACCO LEAFDNA Labs, Inc.161c4738-9ead-4687-9f5a-029d5a496e072025-01-09WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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