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 |
|---|---|---|---|---|---|---|
| Cold Hands - Feet | HISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEA | Newton Laboratories, Inc. | 7a2b4f28-2128-a8b2-e053-2a91aa0a2402 | 2020-11-24 | Warnings | 451W47IQ8X |
| Lactated Ringers | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE | Asclemed USA, Inc. | afac6cc5-1ced-4639-b6f6-86f40ef5c30e | 2020-10-29 | Warnings, Adverse reactions | 451W47IQ8X |
| GUNA ALLERGY | ADRENALINUM - ALLIUM CEPA - AMMONIUM CARBONICUM - APIS MELLIFICA - ARGENTUM NITRICUM - ARSENICUM ALBUM - CUPRUM ACETICUM - GALPHIMIA GLAUCA - GLANDULA SUPRARENALIS SUIS - HISTAMINUM HYDROCHLORICUM - LUFFA OPERCULATA - MATRICARIA CHAMOMILLA - MUCOSA NASALIS SUIS - NATRUM MURIATICUM - SABADILLA - SCILLA MARITIMA - | Guna spa | ae6bd80d-2c70-1a3f-e053-2a95a90a2652 | 2020-10-23 | Warnings | 451W47IQ8X |
| InterSol | PLATELET ADDITIVE 3 | Fenwal, Inc. | a00c4a93-cde2-4753-81f7-0d6fee9fb690 | 2020-10-20 | Warnings, Adverse reactions | 451W47IQ8X 4550K0SC9B |
| SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ac0fd44a-3f39-8d7e-e053-2995a90afeec | 2020-08-04 | Warnings, Adverse reactions | 451W47IQ8X |
| Cardioplegic | CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM CHLORIDE | Baxter Healthcare Corporation | 1fd50ce5-2799-4c26-81da-02cf0578dd9e | 2020-06-11 | Warnings, Adverse reactions | 451W47IQ8X |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a62b71db-8ba2-6f6b-e053-2a95a90a29d1 | 2020-05-21 | Warnings, Adverse reactions | 451W47IQ8X |
| LACTATED RINGERS AND DEXTROSE | SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE | HF Acquisition Co LLC, DBA HealthFirst | a62cf623-9b8a-37e0-e053-2995a90add5b | 2020-05-21 | Warnings, Adverse reactions | 451W47IQ8X |
| Hay Fever | APIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, ALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, AMMONIUM CARBONICUM, ARALIA RACEMOSA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, BELLIS PERENNIS, BERBERIS VULGARIS, BRYONIA, CALLUNA VULGARIS, FLOS, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CISTUS CANADENSIS, DROSERA, DULCAMARA, EUPATORIUM PERFOLIATUM, EUPHRASIA OFFICINALIS, FAGUS SYLVATICA, FRAXINUS AMERICANA, GELSEMIUM SEMPERVIRENS | Newton Laboratories, Inc. | a6045b91-d361-2731-e053-2a95a90a9772 | 2020-05-18 | Warnings | 451W47IQ8X |
| Isolyte S | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | B. Braun Medical Inc. | 7e8fe27f-ff82-48c1-9bf6-3c589c8e985d | 2020-05-14 | Warnings, Adverse reactions | 451W47IQ8X 4550K0SC9B |
| DEXTROSE AND SODIUM CHLORIDE | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE | Fresenius Kabi USA, LLC | b825c9c4-f2fb-4a4a-9d8c-fb020ad07e93 | 2020-04-30 | Warnings, Adverse reactions | 451W47IQ8X |
| db3c178f-a6ec-412b-bcb9-e0bf3aed18c1 | 50fa2e23-0740-41bf-b518-e34bda628b6d | 2020-04-15 | Warnings, Adverse reactions | 50fa2e23-0740-41bf-b518-e34bda628b6d | ||
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a2b8220f-e33a-51c3-e053-2995a90a0734 | 2020-04-07 | Warnings, Adverse reactions | 451W47IQ8X |
| 0.9% SODIUM CHLORIDE | 0.9% SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | a2bba76a-08ce-6902-e053-2995a90ab9c9 | 2020-04-07 | Warnings, Adverse reactions | 451W47IQ8X |
| Dextrose and Electrolyte No. 48 | SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE | Baxter Healthcare Company | b283a454-0c20-4fbf-92d3-dae1f3cd3cad | 2020-02-13 | Warnings, Adverse reactions | 451W47IQ8X |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | fbc01464-8885-4075-af41-911ffec5ae92 | 2020-01-27 | Warnings, Adverse reactions | 451W47IQ8X |
| Plasma-Lyte A | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE | Baxter Healthcare Corporation | 6ec9e61c-2c26-402f-8604-f446b2e34058 | 2019-08-05 | Warnings, Adverse reactions | 451W47IQ8X 4550K0SC9B |
| Potassium Chloride in Dextrose and Sodium Chloride | POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Baxter Healthcare Company | c553fed1-3de5-4826-8eff-633b5923bf0b | 2019-02-21 | Warnings, Adverse reactions | 451W47IQ8X |
| Potassium Chloride in Sodium Chloride | POTASSIUM CHLORIDE AND SODIUM CHLORIDE | Baxter Healthcare Company | becc7410-0a25-49f5-b0c3-240078479dc8 | 2019-01-11 | Warnings, Adverse reactions | 451W47IQ8X |
| Skin Klear Acne Relief | TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR | Homeocare Laboratories | 65afbc20-611b-4bc4-a151-c633bec66a82 | 2018-12-31 | Warnings | 451W47IQ8X |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.