Dexmedetomidine is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Athenex Pharmaceutical Division, Llc.. The primary component is Dexmedetomidine Hydrochloride.
| Product ID | 70860-605_2d4f8489-ded7-4483-be23-352fba49d5ba |
| NDC | 70860-605 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dexmedetomidine |
| Generic Name | Dexmedetomidine |
| Dosage Form | Injection, Solution, Concentrate |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2018-03-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA209065 |
| Labeler Name | Athenex Pharmaceutical Division, 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 | 2022-12-31 |
| Marketing Start Date | 2018-03-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA209065 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-03-01 |
| Marketing Category | ANDA |
| Application Number | ANDA209065 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-03-01 |
| Marketing Category | ANDA |
| Application Number | ANDA209065 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2018-10-24 |
| Ingredient | Strength |
|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | 100 ug/mL |
| SPL SET ID: | afe1ca86-1b9d-44b8-85be-a8a737a12aa1 |
| 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 |