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 |
|---|---|---|---|---|---|---|
| 0.9% Sodium Chloride Saline Solution | SODIUM CHLORIDE | Yunqi Cosmetics (Shenzhen) Co., Ltd | 546af257-dbd1-11fc-e063-6394a90a8e0a | 2026-06-16 | Warnings | 451W47IQ8X |
| BM BM68 DROPS | ARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | BM Private Limited | 53f9c99a-0f20-0358-e063-6394a90af4e0 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BM68 | ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5448c76a-2ecb-9402-e063-6294a90a6ad7 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 544b66c4-49df-556f-e063-6394a90af3ed | 2026-06-15 | Warnings | 451W47IQ8X |
| Male Support | AGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALIS | Deseret Biologicals, Inc. | 29cefc89-3bb6-484e-84ab-116b5827a4c3 | 2026-06-15 | Warnings | 451W47IQ8X |
| BM BM68 DROPS | ARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5410ec88-8c65-3b26-e063-6294a90adf07 | 2026-06-12 | Warnings | 451W47IQ8X |
| V HP | ANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUR | Energique, Inc. | ea12ca3b-19e0-4d4a-9514-4d28d214e1e7 | 2026-06-12 | Warnings | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Cardinal Health 107, LLC | 107af8bc-b6af-4b85-8c8a-ea757dcef1da | 2026-06-12 | Adverse reactions | 451W47IQ8X |
| Jacksons Cell Salts DIGESTIVE BALANCE | NAT MUR, NAT PHOS, NAT SULPH | Zettl Health Inc. | 54018d0e-372f-8afc-e063-6394a90aeb15 | 2026-06-11 | Warnings | 451W47IQ8X |
| GUNA-ALLERGY T | AMMONIUM CARBONATE - APIS MELLIFERA - ARSENIC TRIOXIDE - BLATTA ORIENTALIS - CUPRIC ACETATE - DRIMIA MARITIMA BULB - EPINEPHRINE - GALPHIMIA GLAUCA FLOWERING TOP - HISTAMINE DIHYDROCHLORIDE - LUFFA OPERCULATA - MANGANESE GLUCONATE - ONION - SCHOENOCAULON OFFICINALE SEED - SODIUM CHLORIDE - SUS SCROFA ADRENAL GLAND - SUS SCROFA BRONCHUS - SUS SCROFA NASAL MUCOSA - | Guna spa | fddba85e-2bec-468f-a01a-b71a3aeed9d3 | 2026-06-10 | Warnings | 451W47IQ8X |
| BM BIO28 ALCOHOL | CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA | BM Private Limited | 53d1c51a-77eb-bb3c-e063-6394a90aab3f | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BIO16 | CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR. | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d2c34e-fa4d-9240-e063-6294a90a28da | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BIO20 | CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULF | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53d48847-c0bf-1334-e063-6294a90acf7e | 2026-06-09 | Warnings | 451W47IQ8X |
| BM BM68 | ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUM | BM Private Limited | 53d52b7e-1e84-d4d3-e063-6294a90a9efc | 2026-06-09 | Warnings | 451W47IQ8X |
| Precedex | DEXMEDETOMIDINE HYDROCHLORIDE | Hospira, Inc. | 4419162d-81d4-49bd-96de-1729440bdb74 | 2026-06-09 | Warnings, Adverse reactions | 1018WH7F9I |
| Apizelen | GERMANIUM METALLICUM, ALFALFA, ARALIA QUINQUEFOLIA, AVENA SATIVA, BETA VULGARIS, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), NATRUM MURIATICUM, PALOONDO, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, URTICA DIOICA, VISCUM ALBUM, COBALT ACETATE, COBALT GLUCONATE, COPPER GLUCONATE, CUPRUM ACETICUM, GLUTATHIONE, MAGNESIUM GLUCONICUM DIHYDRICUM, GANODERMA LUCIDUM, UBIDECARENONUM, ARGENTUM METALLICUM | BioActive Nutritional, Inc. | 471a7fab-1ef1-4d13-a28e-75f9762a711a | 2026-06-08 | Warnings | 451W47IQ8X |
| BM Nat Mur | NATRIUM MURIATICUM | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 53baa9ce-5ce6-7bba-e063-6294a90a517a | 2026-06-08 | Warnings | 451W47IQ8X |
| Dexmedetomidine | DEXMEDETOMIDINE | Piramal Critical Care Inc | b93a71ed-0f9e-1ff9-e053-2995a90a789d | 2026-06-03 | Warnings, Adverse reactions | 309710 1018WH7F9I |
| BM Nat Mur Icing Sugar | NATRUM MURIATICUM ICING SUGAR | Total Operations Management LLC DBA:Bestmade Natural Products Micro | 5356d350-1325-7299-e063-6294a90a96a0 | 2026-06-03 | Warnings | 451W47IQ8X |
| Dexmedetomidine Hydrochloride | DEXMEDETOMIDINE HYDROCHLORIDE | Baxter Healthcare Corporation | 7d057255-22a1-4b69-ad7c-7337fac8e993 | 2026-05-29 | Warnings, Adverse reactions | 309710 1018WH7F9I |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.