PRECEDEX is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Dexmedetomidine Hydrochloride.
Product ID | 52584-638_20d3732e-7b12-482d-abb7-24f0719d9a9f |
NDC | 52584-638 |
Product Type | Human Prescription Drug |
Proprietary Name | PRECEDEX |
Generic Name | Dexmedetomidine Hydrochloride |
Dosage Form | Injection, Solution, Concentrate |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2018-07-02 |
Marketing Category | NDA / NDA |
Application Number | NDA021038 |
Labeler Name | General Injectables and Vaccines, Inc. |
Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
Active Ingredient Strength | 100 ug/mL |
Pharm Classes | Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],General Anesthesia [PE] |
NDC Exclude Flag | N |
Listing Certified Through | 2020-12-31 |
Marketing Start Date | 2018-07-02 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | NDA |
Application Number | NDA021038 |
Product Type | HUMAN PRESCRIPTION DRUG |
Marketing Start Date | 2018-07-02 |
Ingredient | Strength |
---|---|
DEXMEDETOMIDINE HYDROCHLORIDE | 100 ug/mL |
SPL SET ID: | 30ee2937-bf84-4c14-bc37-6a6883eea264 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
0404-9938 | PRECEDEX | DEXMEDETOMIDINE HYDROCHLORIDE |
0409-0155 | Precedex | DEXMEDETOMIDINE HYDROCHLORIDE |
0409-1174 | Precedex | DEXMEDETOMIDINE HYDROCHLORIDE |
0409-1434 | Precedex | DEXMEDETOMIDINE HYDROCHLORIDE |
0409-1454 | Precedex | DEXMEDETOMIDINE HYDROCHLORIDE |
0409-1638 | Precedex | DEXMEDETOMIDINE HYDROCHLORIDE |
0409-1660 | Precedex | DEXMEDETOMIDINE HYDROCHLORIDE |
52584-638 | PRECEDEX | PRECEDEX |
0143-9525 | Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride |
0143-9526 | Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride |
0338-9555 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE |
0338-9557 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRECEDEX 75383541 2419482 Live/Registered |
Orion Corporation 1997-11-03 |
PRECEDEX 75197776 not registered Dead/Abandoned |
Orion Corporation 1996-11-13 |