| NDC Code | 0781-3297-95 |
| Package Description | 10 VIAL, SINGLE-USE in 1 CARTON (0781-3297-95) > 2 mL in 1 VIAL, SINGLE-USE (0781-3297-72) |
| Product NDC | 0781-3297 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Dexmedetomidine Hydrochloride |
| Non-Proprietary Name | Dexmedetomidine Hydrochloride |
| Dosage Form | INJECTION, SOLUTION |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20161114 |
| End Marketing Date | 20201231 |
| Marketing Category Name | ANDA |
| Application Number | ANDA091465 |
| Manufacturer | Sandoz Inc |
| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
| Strength | 100 |
| Strength Unit | ug/mL |
| Pharmacy Classes | Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] |