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 | Type |
|---|---|---|---|
| Dexmedetomidine Hydrochloride - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2025-09-22 | HUMAN PRESCRIPTION DRUG LABEL |
| Dexmedetomidine Hydrochloride - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2020-01-22 | Human Prescription Drug Label |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63323-421-01 | Dexmedetomidine Hydrochloride | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | 9 | |
| 63323-421-02 | Dexmedetomidine Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63323-421-01 | ML - Milliliter | 63323-421 | 5be31c1c-261b-4fad-adc2-48c92f3e5d18 | 1 | 2024-04-05 |
| 63323-421-02 | ML - Milliliter | 63323-421 | fe5184cd-2d05-4b8d-942b-eb45f5d8273c | 1 | 2015-12-02 |
| 63323-421-16 | ML - Milliliter | 63323-421 | 1270b335-9970-468c-8a10-dd716c0f16af | 1 | 2016-05-16 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | ACTIVE INGREDIENT | 1018WH7F9I | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| DEXMEDETOMIDINE | ACTIVE MOIETY | 67VB76HONO | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| ACETIC ACID | INACTIVE INGREDIENT | Q40Q9N063P | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM ACETATE | INACTIVE INGREDIENT | 4550K0SC9B | DEXMEDETOMIDINE HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | DEXMEDETOMIDINE 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| EPST PLUS | CARDUUS MARIANUS, CISTUS CANADENSIS, DULCAMARA, GALIUM APARINE, MAGNESIA MURIATICA, NATRUM SULPHURICUM, VISCUM ALBUM, MURIATICUM ACIDUM, FOLLICULINUM, AQUA MARINA, AILANTHUS GLANDULOSUS, BARYTA MURIATICA, CADMIUM METALLICUM, CEANOTHUS AMERICANUS, COCCULUS INDICUS, IRIDIUM METALLICUM, THUJA OCCIDENTALIS, CINCHONA OFFICINALIS, CALCAREA CARBONICA, CROTALUS CASCAVELLA | Deseret Biologicals, Inc. | c2bb50a8-e4f9-4af4-aefc-53c9c3cfcc25 | 2024-02-27 | Warnings | 451W47IQ8X |
| Bladder Relief | CAUSTICUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (VULGARIS), SEPIA, STAPHYSAGRIA, THUJA OCCIDENTALIS | The Magni Company | b09bf037-703f-4c22-8535-b33d586ebefa | 2024-02-08 | Warnings | 451W47IQ8X |
| Dysbio Plus | ACETICUM ACIDUM, ALOE, ARSENICUM ALBUM, BOTULINUM, BRUGIA MALAYI, CHININUM SULPHURICUM, CHOLERA NOSODE, CLOSTRIDIUM DIFFICILE, COLCHICUM AUTUMNALE, COLIBACILLINUM CUM NATRUM MURIATICUM, COLOCYNTHIS, ECHINACEA (ANGUSTIFOLIA), HELICOBACTER PYLORI, HELICOBACTER PYLORI DNA, MERCURIUS CORROSIVUS, MORGAN GAERTNER, NUX VOMICA, PROTEUS (VULGARIS), SALMONELLA TYPHI NOSODE | Deseret Biologicals, Inc. | 6864ab8e-3cf9-460e-b471-84ba3fb2efe0 | 2024-02-07 | Warnings | Q40Q9N063P |
| Dysbio Plus | ECHINACEA (ANGUSTIFOLIA), ALOE, COLCHICUM AUTUMNALE, COLOCYNTHIS, MERCURIUS CORROSIVUS, NUX VOMICA, ARSENICUM ALBUM, ACETICUM ACIDUM, CHININUM SULPHURICUM, CHOLERA NOSODE, PROTEUS (VULGARIS), COLIBACILLINUM CUM NATRUM MURIATICUM, HELICOBACTER PYLORI, BOTULINUM, SALMONELLA TYPHI NOSODE, MORGAN GAERTNER, CLOSTRIDIUM DIFFICILE, BRUGIA MALAYI | Deseret Biologicals, Inc. | 974f23e5-9062-42c1-9df3-12168edee141 | 2024-02-07 | Warnings | Q40Q9N063P |
| hydrocortisone and acetic acid | HYDROCORTISONE AND ACETIC ACID | Cosette Pharmaceuticals, Inc. | cef3713f-11f3-4723-9267-3d79855b49bf | 2024-02-02 | Warnings, Adverse reactions | Q40Q9N063P |
| Dexmedetomidine Hydrochloride | DEXMEDETOMIDINE HYDROCHLORIDE | Par Health USA, LLC | 1ee59985-4c1d-48f7-b8f9-5584c2d55e08 | 2024-02-01 | Warnings, Adverse reactions | 309710 1018WH7F9I |
| Natrum Muriaticum | SODIUM CHLORIDE | SEVENE USA | 11008014-fff6-4d5a-8c5c-a20443d7cc23 | 2024-01-30 | Warnings | 451W47IQ8X |
| LACTATED RINGERS | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a14ca7d9-de30-a303-e053-2a95a90a5304 | 2024-01-27 | Warnings, Adverse reactions | 451W47IQ8X |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | e5247ed5-6170-c13f-e053-2a95a90a4101 | 2024-01-27 | Warnings, Adverse reactions | 451W47IQ8X |
| BSS | BALANCED SALT SOLUTION | Alcon Laboratories, Inc. | 4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea | 2024-01-25 | Warnings, Adverse reactions | 451W47IQ8X 4550K0SC9B |
| CIRCULATION HP | ARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, LACHESIS MUTUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREA, | Energique, Inc. | 464d208b-3893-4ec6-9868-12ef6807b98d | 2024-01-23 | Warnings | 451W47IQ8X |
| DERMA SCALE HP | ARSENICUM IODATUM, BORAX, GRAPHITES, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PETROLEUM, SEPIA, SULPHUR | Energique, Inc. | 64961787-7e9a-4e6f-98ce-0f51934155cf | 2024-01-23 | Warnings | 451W47IQ8X |
| Energy Complex | ECHINACEA (ANGUSTIFOLIA), LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOX, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE) | Health Masters LLC | 9286ca29-8190-4867-9231-b0d68180cb10 | 2024-01-22 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Spectra Medical Deviecs, LLC | 7e316d21-d6ad-4976-bd90-268fd7e51361 | 2024-01-12 | Adverse reactions | 451W47IQ8X |
| A01 CELLULAR RECHARGE | ACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREA | Apex Energetics Inc. | b932ebd3-afea-6a95-e053-2995a90a2735 | 2024-01-08 | Warnings | Q40Q9N063P 451W47IQ8X |
| A12 DTX-KIDNEY | APIS MELLIFICA, BERBERIS VULGARIS, BETULA PUBESCENS BARK, BETULA VERRUCOSA LEAF, BOS TAURUS KIDNEY, BOS TAURUS URINARY BLADDER, CITRICUM ACIDUM, CITRUS LIMONUM, FAGUS SYLVESTRIS FLOWER BUD, NATRUM MURIATICUM, PETROSELINUM SATIVUM, QUERCUS ROBUR FLOWER BUD, SINUSITISINUM, SOLIDAGO VIRGAUREA | Apex Energetics Inc. | bf52e26f-aa27-87ca-e053-2995a90a23e7 | 2024-01-08 | Warnings | 451W47IQ8X |
| B07 DPRSN ANTITOX | ADRENALINUM, AETHUSA CYNAPIUM, AGNUS CASTUS, ALFALFA, ARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, CERATOSTIGMA WILLMOTTIANUM FLOWER, CHERRY PLUM FLOWER, DAMIANA, EUROPEAN ASPEN FLOWER, EUROPEAN HORNBEAM FLOWER, GORSE FLOWER, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, NATRUM MURIATICUM, PASSIFLORA INCARNATA, ROSA CANINA FLOWER, SEPIA, SWEET CHESTNUT FLOWER, THYROIDINUM, WILD MUSTARD FLOWER | Apex Energetics Inc. | bd1fbb76-4f6f-7098-e053-2a95a90ae25c | 2024-01-08 | Warnings | 451W47IQ8X |
| B13 CELL SALT COMPLEX | ALLIUM SATIVUM, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CARBO VEGETABILIS, FERRUM IODATUM, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, PHOSPHORICUM ACIDUM, URTICA URENS | Apex Energetics Inc. | bf78b0b0-5b7b-28cb-e053-2a95a90a1e7d | 2024-01-08 | Warnings | 451W47IQ8X |
| B02 ADRENAL PEP | ACETICUM ACIDUM, ADRENALINUM, AMERICAN GINSENG, ARNICA MONTANA, BALSAMUM PERUVIANUM, BOS TAURUS PITUITARUM POSTERIUM, CHERRY PLUM FLOWER, CHININUM ARSENICOSUM, CINCHONA OFFICINALIS, CLEMATIS VITALBA FLOWER, DAMIANA, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE FLOWER, GLYCYRRHIZA GLABRA, IMPATIENS GLANDULIFERA FLOWER, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYRENEES STAR OF BETHLEHEM, ROCKROSE FLOWER, SELENIUM METALLICUM, THYROIDINUM | Apex Energetics Inc. | bad63b2e-63b4-ee97-e053-2a95a90a82e4 | 2024-01-08 | Warnings | Q40Q9N063P |
| F01 ANGR-RLS | BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CHAMOMILE FLOWER, CHICORY FLOWER, GARLIC, ENGLISH HOLLY FLOWER, EUROPEAN BEECH FLOWER, FORKING LARKSPUR FLOWER, GERMAN CHAMOMILE FLOWER, IMPATIENS GLANDULIFERA FLOWER, LILIUM TIGRINUM, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, RUBBER RABBITBRUSH, VITIS VINIFERA FLOWER, WATERMELON, WHITE WILLOW FLOWER, YELLOW STAR THISTLE | Apex Energetics Inc. | bd0b2eab-b6eb-19ce-e053-2a95a90aebe6 | 2024-01-08 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.