| Product NDC: | 55648-780 |
| 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 |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 55648-780 |
| Labeler Name: | Wockhardt Limited |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA077834 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20081030 |
| Package NDC: | 55648-780-01 |
| Package Description: | 1 VIAL in 1 CARTON (55648-780-01) > 18 mL in 1 VIAL |
| NDC Code | 55648-780-01 |
| Proprietary Name | Amiodarone Hydrochloride |
| Package Description | 1 VIAL in 1 CARTON (55648-780-01) > 18 mL in 1 VIAL |
| Product NDC | 55648-780 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Amiodarone Hydrochloride |
| Dosage Form Name | INJECTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20081030 |
| Marketing Category Name | ANDA |
| Labeler Name | Wockhardt Limited |
| Substance Name | AMIODARONE HYDROCHLORIDE |
| Strength Number | 50 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Antiarrhythmic [EPC] |