DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc.. The primary component is Dexmedetomidine Hydrochloride.
| Product ID | 0781-3493_a7ea3417-a8d8-9d52-e053-2a95a90ae8bc |
| NDC | 0781-3493 |
| Product Type | Human Prescription Drug |
| Proprietary Name | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
| Generic Name | Dexmedetomidine Hydrochloride In 0.9% Sodium Chloride |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2020-06-12 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA209065 |
| Labeler Name | Sandoz Inc. |
| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
| Active Ingredient Strength | 4 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 | 2020-06-12 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0781-3493 | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
| 0781-3494 | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
| 0781-3495 | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
| 43066-555 | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride |
| 43066-557 | DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE in 0.9% sodium chloride |
| 55150-296 | Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride |
| 55150-297 | Dexmedetomidine Hydrochloride | Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride |