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 |
|---|---|---|---|---|---|---|
| Hydrate 2 | BERBERISAQUIFOLIUM,BETAVULGARIS,BOLDO,CHELIDONIUMMAJUS,HORDEUMVULGARE,IRISVERSICOLOR,ROSMARINUSOFFICINALIS,CARDUUSMARIANUS,TARAXACUMOFFICINALE,AVENASATIVA,ELEUTHEROCOCCUSSENTICOSUS,XANTHOXYLUMFRAXINEUM,EQUISETUMHYEMALE,HYPERICUMPERFORATUM,ULMUSFULVA,GETTYSBURGAQUA,GLYCYRRHIZAGLABRA,WILDBADAQUA,CARLSBADAQUA,ATP,HYDROGEN,NATRUMMURIATICUM,OXYGEN,SILICEA,WIESBADENAQUA | Natural Creations, Inc | 52cb98dc-6858-42bf-9c54-d20fb607dfbb | 2021-11-12 | Warnings | 451W47IQ8X |
| Adrenal and DHEA | ARALIA QUINQUEFOLIA, ASHWAGANDHA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, RHODIOLA. | ProBLEN | 44991952-c440-4a33-9423-a9369c8bab70 | 2021-10-22 | Warnings | 451W47IQ8X |
| Dr. Talbots Daily Allergy Relief | ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM | Talbot's Pharmaceuticals Family Products, LLC. | 91c2795d-4cde-6e2c-e053-2995a90a0096 | 2021-10-05 | Warnings | 451W47IQ8X |
| Solucion InterSol | SOLUCION ADITIVA PARA PLAQUETAS 3 | Fenwal, Inc. | d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1 | 2021-10-04 | Warnings, Adverse reactions | 451W47IQ8X 4550K0SC9B |
| NATRUM MURIATICUM | NATRUM MURIATICUM | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc | 520edb18-5f2a-4448-ba53-83408a839e1f | 2021-09-02 | Warnings | 451W47IQ8X |
| Lactated Ringers Irrigation | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE | B. Braun Medical Inc. | 0db56c7a-2b8f-4593-8591-2c481c92b2cf | 2021-08-06 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride for Irrigation | SODIUM CHLORIDE FOR IRRIGATION | B. Braun Medical Inc. | 5bd9b176-0402-4a3f-a6b4-c3f393fc092a | 2021-08-06 | Warnings, Adverse reactions | 451W47IQ8X |
| 0.9% SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | c755e41b-acba-7234-e053-2995a90aff0f | 2021-07-17 | Warnings, Adverse reactions | 451W47IQ8X |
| Melange combination | CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA | Seroyal USA | 0a071fbf-0075-4479-e054-00144ff8d46c | 2021-07-14 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 4a655cde-283f-4ec8-a3d9-5f539c55c204 | 2021-05-10 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ed8fd0c1-ac42-4267-877e-ceadf3831c90 | 2021-04-29 | Warnings, Adverse reactions | 451W47IQ8X |
| Dr. Talbots Vital 12 | CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUC | Talbot's Pharmaceuticals Family Products, LLC | c10bb804-8169-63da-e053-2a95a90a8306 | 2021-04-28 | Warnings | 451W47IQ8X |
| Dr. Talbots Infant Daily Allergy Relief | ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM | Talbot's Pharmaceuticals Family Products, LLC | c0963200-67dd-6349-e053-2a95a90adde1 | 2021-04-22 | Warnings | 451W47IQ8X |
| CLINIMIX E | LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE | Baxter Healthcare Company | 8469d6fb-d6ef-476f-8cc3-0905192de0a8 | 2021-04-13 | Warnings, Adverse reactions | 451W47IQ8X 4550K0SC9B |
| Sodium Chloride | SODIUM CHLORIDE | Medical Purchasing Solutions, LLC | c3f8e83c-4fb9-91da-e053-2a95a90abd63 | 2021-04-12 | Adverse reactions | 451W47IQ8X |
| CVS Health Sterile Saline Mist Live Better | SODIUM CHLORIDE | CVS Pharmacy | ccc3ab8c-b22f-420d-869b-f2a65b8c7180 | 2021-03-13 | Warnings | 451W47IQ8X |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | aeaed9cb-b629-4019-88d2-a916179427de | 2021-02-19 | Warnings, Adverse reactions | 451W47IQ8X |
| GUNA KIDNEY PLUS | CALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP - | Guna spa | b8dacd94-8da1-4a8d-e053-2995a90acb67 | 2021-02-04 | Warnings | 451W47IQ8X |
| Natrum Muriaticum | NATRUM MURIATICUM | True Botanica, LLC | b30b2880-28a1-47bd-83e7-da885a7c6f77 | 2021-01-24 | Warnings | 451W47IQ8X |
| Metabolic Reset | ACETICUM ACIDUM, ANACARDIUM ORIENTALE, BARYTA IODATA, CALCAREA CARBONICA, CAPSICUM ANNUM, FOCUS VERSICULOSUS, GRAPHITES, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, STANNUM METALLICUM, THYROIDINUM, ZINCUM METALLICUM | Hanoun, Andrew Functional Medicine Inc. | 2a3dd066-ec16-493d-a3b2-2bb5eb2e321c | 2021-01-21 | Warnings | Q40Q9N063P |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.