| NDC Code | 52584-348-35 |
| Package Description | 1 AMPULE in 1 BAG (52584-348-35) > 3 mL in 1 AMPULE |
| Product NDC | 52584-348 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Amiodarone Hydrochloride |
| Non-Proprietary Name | Amiodarone Hydrochloride |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Usage | INTRAVENOUS |
| Start Marketing Date | 20100301 |
| Marketing Category Name | ANDA |
| Application Number | ANDA075955 |
| Manufacturer | General Injectables & Vaccines, Inc. |
| Substance Name | AMIODARONE HYDROCHLORIDE |
| Strength | 50 |
| Strength Unit | mg/mL |
| Pharmacy Classes | Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA],Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA] |