NDC Code | 52584-638-02 |
Package Description | 1 VIAL in 1 BAG (52584-638-02) > 2 mL in 1 VIAL |
Product NDC | 52584-638 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Precedex |
Non-Proprietary Name | Dexmedetomidine Hydrochloride |
Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
Usage | INTRAVENOUS |
Start Marketing Date | 20180702 |
End Marketing Date | 20230901 |
Marketing Category Name | NDA |
Application Number | NDA021038 |
Manufacturer | General Injectables and Vaccines, 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] |