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 | Type |
|---|---|---|---|
| Dexmedetomidine Hydrochloride - Fresenius Kabi USA, LLC | Fresenius Kabi USA, LLC | 2026-01-23 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65219-642-01 | Dexmedetomidine Hydrochloride | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | 1 | |
| 65219-642-02 | Dexmedetomidine Hydrochloride | 25 in 1 TRAY | INJECTION, SOLUTION | 25 | 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 |
|---|---|---|---|---|---|---|
| HA HP | BELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIA | BioActive Nutritional, Inc. | 30f6c191-ce6e-438c-9601-74f5e8b61f96 | 2018-07-06 | Warnings | 451W47IQ8X |
| Metabolic Support | FUCUS VESICULOSUS, AGNUS CASTUS, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHYTOLACCA DECANDRA, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, CARBO VEGETABILIS, GRAPHITES, CALCAREA CARBONICA, NATRUM PHOSPHORICUM, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, THYROIDINUM (SUIS) | BodyLogicMD of Fort Lauderdale | c2a1bd6d-c595-402f-a3bc-23f64c949d78 | 2018-06-08 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 181705c7-40e4-4d7d-b9ea-ada99380e7a9 | 2018-05-23 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 7c72520e-de3c-493d-8aea-11933376d968 | 2018-04-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Acetic Acid | ACETIC ACID | Baxter Healthcare Corporation | 41bc12af-fac5-4ac1-b907-dcb3e35a054c | 2018-02-02 | Warnings, Adverse reactions | Q40Q9N063P |
| Lactated Ringers | SODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE | Baxter Healthcare Company | 5215ec33-8cfe-4885-ae92-e6a12100bd27 | 2018-01-02 | Warnings, Adverse reactions | 451W47IQ8X |
| Homeoplex D | GLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, | Supplement Clinic, LLC. | cd6b48ab-3566-484d-8deb-15ef6f8e7e8f | 2017-11-01 | Warnings | Q40Q9N063P |
| Homeoplex B | ARSENICUM ALBUM, CALCAREA CARBONICA , IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA, STAPHYSAGRIA | Supplement Clinic, LLC. | e9a9c58e-1b70-4ac8-9d9c-108c628d7664 | 2017-10-31 | Warnings | 451W47IQ8X |
| Spleen-Pro T018 | SPLEEN (SUIS), ARSENICUM ALBUM, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CHININUM SULPHURICUM, IGNATIA AMARA, IODIUM, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS | Guangzhou Renuma Medical Systems Co., Ltd | bc2b70bd-2a4a-46fb-b3d8-d69b61056b89 | 2017-10-26 | Warnings | 451W47IQ8X |
| Glucose Control T015 | SYZYGIUM JAMBOLANUM, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, PANCREAS SUIS, PHASEOLUS, ACETICUM ACIDUM, LACTICUM ACIDUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, URANIUM NITRICUM | Guangzhou Renuma Medical Systems Co., Ltd | 3fd02c0a-5cf1-4f35-86d0-d5d09e63f39b | 2017-10-26 | Warnings | Q40Q9N063P |
| Female Vitality T010 | CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA | Guangzhou Renuma Medical Systems Co., Ltd | 694f0c36-b656-471a-9f38-2efb5193e05a | 2017-10-20 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Company | 886f889b-f3cf-4197-b307-6cfa88c89436 | 2017-05-04 | 451W47IQ8X | |
| ReHydration | ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE) | Energetix Corp | 9883c502-9782-451e-9eec-c54d7b054f31 | 2017-01-31 | Warnings | 451W47IQ8X |
| Tox-Chord | ALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUM | Energetix Corp | 6b0d1628-b20d-426e-9c84-5cceadca3f45 | 2016-11-11 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 2a96096d-43cc-49b7-af53-b53c17f41001 | 2014-07-25 | Warnings, Adverse reactions | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | b3b4b176-41f0-4ca8-90d4-3fba5707564a | 2014-02-21 | 451W47IQ8X | |
| TIS-U-SOL | SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE | Baxter Healthcare Corporation | 9da4121f-d62d-4da4-8dfb-0494da16015f | 2014-02-21 | 451W47IQ8X | |
| Ringers | SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, | Baxter Healthcare Corporation | e1953d54-818d-46a6-8532-518ebae6d84e | 2012-06-13 | 451W47IQ8X | |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE | Baxter Healthcare Corporation | f09f80bf-2f8b-4420-865d-aec2d5e5cd4d | 2012-06-12 | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.