| NDC Code | 0781-3495-95 |
| Package Description | 10 BOTTLE in 1 CARTON (0781-3495-95) / 100 mL in 1 BOTTLE |
| Product NDC | 0781-3495 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride |
| Non-Proprietary Name | Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride |
| Dosage Form | INJECTION |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20200612 |
| Marketing Category Name | ANDA |
| Application Number | ANDA209065 |
| Manufacturer | Sandoz Inc. |
| 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] |