| NDC Code | 69271-046-01 |
| Package Description | 1 VIAL in 1 CARTON (69271-046-01) / 250 mL in 1 VIAL |
| Product NDC | 69271-046 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Precedex Dexmedetomidine Hci Chloride |
| Non-Proprietary Name | Dexmedetomidine Hydrochloride, Sodium Chloride |
| Dosage Form | INJECTION, SOLUTION |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20230221 |
| Marketing Category Name | NDA |
| Application Number | NDA021038 |
| Manufacturer | Fareva Amboise |
| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
| Strength | 4 |
| Strength Unit | ug/mL |
| Pharmacy Classes | Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE] |