| NDC Code | 63323-671-20 |
|---|
| Package Description | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-671-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-671-02) |
|---|
| Product NDC | 63323-671 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Dexmedetomidine Hydrochloride |
|---|
| Non-Proprietary Name | Dexmedetomidine Hydrochloride |
|---|
| Dosage Form | INJECTION, SOLUTION |
|---|
| Usage | INTRAVENOUS |
|---|
| Start Marketing Date | 20190513 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA208129 |
|---|
| Manufacturer | Fresenius Kabi USA, 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] |
|---|