| NDC Code | 70771-1319-7 |
| Package Description | 25 VIAL in 1 CARTON (70771-1319-7) > 2 mL in 1 VIAL (70771-1319-1) |
| Product NDC | 70771-1319 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Dexmedetomidine Hydrochloride |
| Non-Proprietary Name | Dexmedetomidine Hydrochloride |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20180614 |
| Marketing Category Name | ANDA |
| Application Number | ANDA206798 |
| Manufacturer | Zydus Lifesciences Limited |
| 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] |