Dexmedetomidine is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Dexmedetomidine Hydrochloride.
| Product ID | 17478-055_30f03f77-f1cb-4ff3-b646-59509e662d1a |
| NDC | 17478-055 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dexmedetomidine |
| Generic Name | Dexmedetomidine Hydrochloride |
| Dosage Form | Injection, Solution, Concentrate |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2014-11-24 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202585 |
| Labeler Name | Akorn |
| 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 | 2023-12-31 |
| Marketing Start Date | 2014-11-24 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA202585 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2014-11-24 |
| Ingredient | Strength |
|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | 100 ug/mL |
| SPL SET ID: | 8fb7886c-7762-4b72-989b-0fe8e963b4b8 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 70860-605 | Dexmedetomidine | Dexmedetomidine |
| 71872-7150 | Dexmedetomidine | Dexmedetomidine |
| 17478-055 | Dexmedetomidine | Dexmedetomidine |
| 57884-3091 | DEXMEDETOMIDINE | DEXMEDETOMIDINE |
| 67457-251 | Dexmedetomidine | Dexmedetomidine |
| 71288-505 | DEXMEDETOMIDINE | DEXMEDETOMIDINE |
| 16729-239 | Dexmedetomidine | Dexmedetomidine |
| 66794-230 | Dexmedetomidine | Dexmedetomidine |
| 16729-432 | DEXMEDETOMIDINE | DEXMEDETOMIDINE |
| 55150-209 | Dexmedetomidine | Dexmedetomidine |
| 0143-9525 | Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride |
| 0143-9526 | Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride |
| 0338-9555 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE |
| 0338-9557 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE |
| 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 |