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] |