| NDC Code | 70121-1712-3 |
|---|
| Package Description | 12 POUCH in 1 CARTON (70121-1712-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG |
|---|
| Product NDC | 70121-1712 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Dexmedetomidine Hydrochloride |
|---|
| Non-Proprietary Name | Dexmedetomidine Hydrochloride In Sodium Chloride |
|---|
| Dosage Form | INJECTION |
|---|
| Usage | INTRAVENOUS |
|---|
| Start Marketing Date | 20230519 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA216604 |
|---|
| Manufacturer | Amneal Pharmaceuticals LLC |
|---|
| Substance Name | DEXMEDETOMIDINE HYDROCHLORIDE |
|---|
| Strength | 4 |
|---|
| Strength Unit | ug/mL |
|---|
| Pharmacy Classes | Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE] |
|---|