FDA.reportPublic FDA data

NDC 63323-421-01 - 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
63323-421
Requested NDC
63323-421-01
Package NDCs from labels
63323-421-01, 63323-421-02, 63323-421-16
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2025-09-22
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, LLC2025-09-22HUMAN PRESCRIPTION DRUG LABEL
Dexmedetomidine Hydrochloride - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2020-01-22Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-421-01Dexmedetomidine Hydrochloride2 mL in 1 VIALINJECTION, SOLUTION29
63323-421-02Dexmedetomidine Hydrochloride25 in 1 TRAYINJECTION, SOLUTION259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-421DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 2 package rows20221123_c1b8eb58-596b-481d-beb6-ba9d2237abf4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-421-01ML - Milliliter63323-4215be31c1c-261b-4fad-adc2-48c92f3e5d1812024-04-05
63323-421-02ML - Milliliter63323-421fe5184cd-2d05-4b8d-942b-eb45f5d8273c12015-12-02
63323-421-16ML - Milliliter63323-4211270b335-9970-468c-8a10-dd716c0f16af12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXMEDETOMIDINE HYDROCHLORIDEACTIVE INGREDIENT1018WH7F9IDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
DEXMEDETOMIDINEACTIVE MOIETY67VB76HONODEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1

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 39 of 49 · 965 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetic AcidACETIC ACIDB. Braun Medical Inc.dd45cee3-9938-4dad-a5e1-1dd4baea85a92023-08-23Warnings, Adverse reactionsExact identifier
unii: Q40Q9N063P
BABY MUCUS PLUS COLD RELIEFBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.d934cc8a-1e43-4942-858a-05b5d068679a2023-08-22WarningsExact identifier
unii: 451W47IQ8X
Hepaticol SarcodeCARDUUS MARIANUS, ZINGIBER OFFICINALE, BERBERIS VULGARIS, CHELIDONIUM MAJUS, MAGNESIA MURIATICA, LEPTANDRA VIRGINICA, NATRUM MURIATICUM, BRYONIA (ALBA), HEPAR (BOVINE), NATRUM SULPHURICUM, ATROPINUM SULPHURICUM, LYCOPODIUM CLAVATUMNutritional Specialties, Inc.f9d95b2f-53d9-4017-873f-5ad0b129f9f82023-08-14WarningsExact identifier
unii: 451W47IQ8X
CellergyCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA.Ratis, LLC2aebc11e-eeb7-436b-b90c-3a2f59fb74922023-08-07WarningsExact identifier
unii: 451W47IQ8X
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f3bcf-0e45-d390-e063-6394a90a588e2023-07-28WarningsExact identifier
unii: 451W47IQ8X
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f0210-195d-11d7-e063-6294a90aa7502023-07-27WarningsExact identifier
unii: 451W47IQ8X
Melatonin ProCALCAREA CARBONICA, CHAMOMILLA, COCCULUS INDICUS, COFFEA CRUDA, FERRUM PHOSPHORICUM, KALI PHOSPHORICUM, MAGNESIA CARBONICA, MELATONIN, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS)Energique, Inc.1f374642-83f7-4e64-b330-0f6ef21000a92023-07-19WarningsExact identifier
unii: 451W47IQ8X
Gum TherapyCALENDULA OFFICINALIS, KALI PHOSPHORICUM, NATRUM MURIATICUM, ARNICA MONTANA, AGAVE AMERICANA, CISTUS CANADENSIS, KREOSOTUM, MYRRHA, CALCAREA FLUORICA, ACONITUM NAPELLUS, BISMUTHUM SUBNITRICUM, SEPIA, HEPAR SULPHURIS CALCAREUM, MERCURIUS VIVUSDeseret Biologicals0cf8a815-808d-4018-baf9-2b4545fc7ea82023-07-19WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLCb6e33138-841a-471f-a934-c4086cbc23f62023-07-17Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
AnpituaparHYPOPHYSIS SUIS, AGNUS CASTUS, BARYTA CARBONICA, CALCAREA CARBONICA, IODIUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SEPIA, THYROIDINUM (SUIS), LAC CANINUM, ADRENOCORTICOTROPHINEnergique, Inc.c0ed2996-8eb5-43f7-b3cc-17477af7f7e92023-07-13WarningsExact identifier
unii: 451W47IQ8X
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 451W47IQ8X
ThyrostatFUCUS VESICULOSUS, SPONGIA TOSTA, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), ARSENICUM IODATUM, BARYTA CARBONICA, IODIUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUMEnergique, Inc.5c41b36c-e28f-4d60-b9b9-6b888d55ea952023-07-12WarningsExact identifier
unii: 451W47IQ8X
Introvert FormulaPASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, NATRUM MURIATICUM, DUODENUM (SUIS), PETROLEUM, SULPHURNutritional Specialties, Inc.522148c9-0bc0-44c9-8876-70051224c9512023-07-11WarningsExact identifier
unii: 451W47IQ8X
Aceticum acidumACETIC ACIDBoiron69214a87-0b8c-702d-e053-2a91aa0a34162023-07-03Exact identifier
unii: Q40Q9N063P
Hypercalm-Mental FocusCHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDENewton Laboratories, Inc.ff5f22e1-74ee-1eee-e053-6394a90a26782023-06-30WarningsExact identifier
unii: 451W47IQ8X
Hypercalm-Mental FocusCHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDENewton Laboratories, Inc.ff604442-4697-e2bb-e053-6394a90a03402023-06-30WarningsExact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron86455058-2722-5c0a-e053-2a91aa0ac6592023-06-26Exact identifier
unii: 451W47IQ8X
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.fecece1f-22bc-21dc-e053-6294a90ad0c32023-06-23WarningsExact identifier
unii: 451W47IQ8X
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.fed03a1c-0ea8-1f8e-e053-6394a90a04c02023-06-23WarningsExact identifier
unii: 451W47IQ8X
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.febf610e-e08a-4797-e053-6294a90a3eb52023-06-22WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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