Amiodarone Hydrochloride is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Amiodarone Hydrochloride.
| Product ID | 52584-616_ed10efa1-7b31-4146-9665-8dc480da1323 |
| NDC | 52584-616 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Amiodarone Hydrochloride |
| Generic Name | Amiodarone Hydrochloride |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2017-06-07 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA075761 |
| Labeler Name | General Injectables and Vaccines, Inc. |
| Substance Name | AMIODARONE HYDROCHLORIDE |
| Active Ingredient Strength | 50 mg/mL |
| 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 | E |
| Listing Certified Through | 2018-12-31 |
| Marketing Start Date | 2017-06-07 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA075761 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-06-07 |
| Marketing End Date | 2019-06-30 |
| Ingredient | Strength |
|---|---|
| AMIODARONE HYDROCHLORIDE | 50 mg/mL |
| SPL SET ID: | 744decb0-d37c-48ec-8d0c-f9774b6b0d40 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9875 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 0185-0144 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 0404-9815 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 0615-4545 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 0615-8213 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 0615-8258 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 0904-6556 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 0904-6993 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 21695-796 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 25021-302 | amiodarone hydrochloride | amiodarone hydrochloride |
| 29300-359 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 42291-118 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 42291-139 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 68083-112 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 68084-371 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE |
| 68382-227 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 70518-1231 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 70518-1939 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 70518-1571 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 71335-0881 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 71872-7149 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 71872-7000 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 50090-2308 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 50090-3015 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 50090-3496 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 51662-1205 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE |
| 51672-4025 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 51862-240 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 51672-4057 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 51672-4056 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 51862-242 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 51672-4055 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 51862-241 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 52584-616 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 52584-063 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE |
| 53808-1066 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 55150-180 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 55154-4996 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE |
| 55150-182 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 55154-5492 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 55150-181 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 55648-780 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 55648-739 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 60505-2658 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 63323-616 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |
| 63629-7300 | Amiodarone hydrochloride | Amiodarone hydrochloride |
| 63739-387 | Amiodarone Hydrochloride | Amiodarone Hydrochloride |