| NDC Code | 63323-724-05 |
| Package Description | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-724-05) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-724-01) |
| Product NDC | 63323-724 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Remifentanil Hydrochloride |
| Non-Proprietary Name | Remifentanil Hydrochloride |
| Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20180119 |
| Marketing Category Name | ANDA |
| Application Number | ANDA206223 |
| Manufacturer | Fresenius Kabi USA, LLC |
| Substance Name | REMIFENTANIL HYDROCHLORIDE |
| Strength | 1 |
| Strength Unit | mg/mL |
| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC] |
| DEA Schedule | CII |