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 |
|---|---|---|---|---|---|---|
| Thyrostat | FUCUS VESICULOSUS, SPONGIA TOSTA, HYPOPHYSIS SUIS, THYROIDINUM (SUIS), ARSENICUM IODATUM, BARYTA CARBONICA, IODIUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM | Energique, Inc. | 5c41b36c-e28f-4d60-b9b9-6b888d55ea95 | 2023-07-12 | Warnings | 451W47IQ8X |
| Introvert Formula | PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), IGNATIA AMARA, NATRUM MURIATICUM, DUODENUM (SUIS), PETROLEUM, SULPHUR | Nutritional Specialties, Inc. | 522148c9-0bc0-44c9-8876-70051224c951 | 2023-07-11 | Warnings | 451W47IQ8X |
| Aceticum acidum | ACETIC ACID | Boiron | 69214a87-0b8c-702d-e053-2a91aa0a3416 | 2023-07-03 | Q40Q9N063P | |
| Hypercalm-Mental Focus | CHAMOMILLA, 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 VIRIDE | Newton Laboratories, Inc. | ff5f22e1-74ee-1eee-e053-6394a90a2678 | 2023-06-30 | Warnings | 451W47IQ8X |
| Hypercalm-Mental Focus | CHAMOMILLA, 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 VIRIDE | Newton Laboratories, Inc. | ff604442-4697-e2bb-e053-6394a90a0340 | 2023-06-30 | Warnings | 451W47IQ8X |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 86455058-2722-5c0a-e053-2a91aa0ac659 | 2023-06-26 | 451W47IQ8X | |
| Hyperactivity-Mental Focus | ADRENALINUM, 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, PASSIFLORA | Newton Laboratories, Inc. | fecece1f-22bc-21dc-e053-6294a90ad0c3 | 2023-06-23 | Warnings | 451W47IQ8X |
| Hyperactivity-Mental Focus | ADRENALINUM, 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, PASSIFLORA | Newton Laboratories, Inc. | fed03a1c-0ea8-1f8e-e053-6394a90a04c0 | 2023-06-23 | Warnings | 451W47IQ8X |
| Hyperactivity-Mental Focus | ADRENALINUM, 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, PASSIFLORA | Newton Laboratories, Inc. | febf610e-e08a-4797-e053-6294a90a3eb5 | 2023-06-22 | Warnings | 451W47IQ8X |
| PEG-3350 and Electrolytes | POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE | A-S Medication Solutions | 7a2d8dab-750f-43c1-933c-4169a840c60c | 2023-06-20 | Warnings, Adverse reactions | 451W47IQ8X |
| Grain and Seed Antigens | AMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR | BioActive Nutritional, Inc. | 36ce44a5-e5ac-4eea-b76d-424dcd4e6b07 | 2023-06-20 | Warnings | 451W47IQ8X |
| Vital Skin Hair Nails | L-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALIS | Liddell Laboratories, Inc. | 3e8a9233-6e65-4023-b3f8-8bca369a9c2a | 2023-06-15 | Warnings | 451W47IQ8X |
| Endopar F | CIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIA | Energique, Inc. | d186ae0e-0dc3-48e7-9e22-6778bb80ad18 | 2023-06-07 | Warnings | 451W47IQ8X |
| Dexmedetomidine Hydrochloride | DEXMEDETOMIDINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | a268e759-9a3e-1d7b-e053-2a95a90a335b | 2023-06-01 | Warnings, Adverse reactions | 309710 1018WH7F9I |
| Dexmedetomidine hydrochloride | DEXMEDETOMIDINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | a2666c50-3b55-1380-e053-2a95a90aea58 | 2023-06-01 | Warnings, Adverse reactions | 309710 1018WH7F9I |
| Cyclease PMS | ESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICE | Laboratoires Boiron | 09ff0633-2992-4aba-96ed-45a69f3ee589 | 2023-05-30 | Warnings | 451W47IQ8X |
| Dexmedetomidine Hydrochloride | DEXMEDETOMIDINE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 6937235f-ea25-4950-e053-2991aa0a9b74 | 2023-05-23 | Warnings, Adverse reactions | 309710 1018WH7F9I |
| BACTERIOSTATIC SODIUM CHLORIDE | SODIUM CHLORIDE | Medical Purchasing Solutions, LLC | 8a0d24a9-d02a-0379-e053-2a95a90af712 | 2023-05-23 | Boxed warning, Warnings, Adverse reactions | 451W47IQ8X |
| Histastat Pollen | BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDES | Energique, Inc. | 00478787-ccec-4101-a0da-fd337037c3ee | 2023-05-12 | Warnings | 451W47IQ8X |
| Dexmedetomidine HCl | DEXMEDETOMIDINE HCL | Medical Purchasing Solutions, LLC | ada70a68-3e52-4b94-e053-2995a90aa1e0 | 2023-05-03 | Warnings, Adverse reactions | 309710 1018WH7F9I |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.