Amiodarone Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Advagen Pharma Limited. The primary component is Amiodarone Hydrochloride.
| Product ID | 72888-060_bfee5768-6164-52f7-e053-2995a90aeeb1 |
| NDC | 72888-060 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Amiodarone Hydrochloride |
| Generic Name | Amiodarone Hydrochloride |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2020-08-21 |
| Marketing Category | ANDA / |
| Application Number | ANDA078578 |
| Labeler Name | Advagen Pharma Limited |
| Substance Name | AMIODARONE HYDROCHLORIDE |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2020-08-21 |
| NDC Exclude Flag | N |
| Sample Package? | N |