| Product NDC: | 67457-153 |
| Proprietary Name: | Amiodarone Hydrochloride |
| Non Proprietary Name: | amiodarone hydrochloride |
| Active Ingredient(s): | 50 mg/mL & nbsp; amiodarone hydrochloride |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 67457-153 |
| Labeler Name: | Mylan Institutional LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076217 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20130604 |
| Package NDC: | 67457-153-09 |
| Package Description: | 10 VIAL, GLASS in 1 CARTON (67457-153-09) > 9 mL in 1 VIAL, GLASS (67457-153-99) |
| NDC Code | 67457-153-09 |
| Proprietary Name | Amiodarone Hydrochloride |
| Package Description | 10 VIAL, GLASS in 1 CARTON (67457-153-09) > 9 mL in 1 VIAL, GLASS (67457-153-99) |
| Product NDC | 67457-153 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | amiodarone hydrochloride |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20130604 |
| Marketing Category Name | ANDA |
| Labeler Name | Mylan Institutional LLC |
| Substance Name | AMIODARONE HYDROCHLORIDE |
| Strength Number | 50 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Antiarrhythmic [EPC] |