Dexmedetomidine is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Dexmedetomidine Hydrochloride.
Product ID | 67457-251_0139b0bb-7409-4d68-aaf9-add9f3408439 |
NDC | 67457-251 |
Product Type | Human Prescription Drug |
Proprietary Name | Dexmedetomidine |
Generic Name | Dexmedetomidine |
Dosage Form | Injection, Solution, Concentrate |
Route of Administration | INTRAVENOUS |
Marketing Start Date | 2014-08-18 |
Marketing Category | ANDA / ANDA |
Application Number | ANDA202881 |
Labeler Name | Mylan Institutional LLC |
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 | 2021-12-31 |
Marketing Start Date | 2014-08-18 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | ANDA |
Application Number | ANDA202881 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2014-08-18 |
Marketing Category | ANDA |
Application Number | ANDA202881 |
Product Type | HUMAN PRESCRIPTION DRUG |
Billing Unit | ML |
Marketing Start Date | 2014-08-18 |
Ingredient | Strength |
---|---|
DEXMEDETOMIDINE HYDROCHLORIDE | 100 ug/mL |
SPL SET ID: | ebdfe2e8-30ca-4f18-935a-41bcbbce4937 |
Manufacturer | |
UNII | |
RxNorm Concept Unique ID - RxCUI |
NDC | Brand Name | Generic Name |
---|---|---|
16729-239 | Dexmedetomidine | Dexmedetomidine |
16729-432 | DEXMEDETOMIDINE | DEXMEDETOMIDINE |
17478-055 | Dexmedetomidine | Dexmedetomidine Hydrochloride |
55150-209 | Dexmedetomidine | Dexmedetomidine |
57884-3091 | DEXMEDETOMIDINE | DEXMEDETOMIDINE |
66794-230 | Dexmedetomidine | Dexmedetomidine |
66794-233 | Dexmedetomidine | Dexmedetomidine |
66794-238 | Dexmedetomidine | Dexmedetomidine |
67457-251 | Dexmedetomidine | dexmedetomidine |
70860-605 | Dexmedetomidine | dexmedetomidine |
71288-505 | DEXMEDETOMIDINE | DEXMEDETOMIDINE |
71872-7150 | Dexmedetomidine | dexmedetomidine |
81092-1120 | IGALMI | DEXMEDETOMIDINE |
81092-1180 | IGALMI | DEXMEDETOMIDINE |