Home
>
National Drug Code (NDC)
>
Amiodarone Hydrochloride
Amiodarone Hydrochloride - 52584-348-35 - (Amiodarone Hydrochloride)
Drug Information of Amiodarone Hydrochloride
| Product NDC: | 52584-348 |
| 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, CONCENTRATE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Amiodarone Hydrochloride
| Product NDC: | 52584-348 |
| Labeler Name: | General Injectables & Vaccines, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA075955 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20100301 |
Package Information of Amiodarone Hydrochloride
| Package NDC: | 52584-348-35 |
| Package Description: | 1 AMPULE in 1 BAG (52584-348-35) > 3 mL in 1 AMPULE |
NDC Information of Amiodarone Hydrochloride
| NDC Code | 52584-348-35 |
| Proprietary Name | Amiodarone Hydrochloride |
| 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 |
| Non Proprietary Name | Amiodarone Hydrochloride |
| Dosage Form Name | INJECTION, SOLUTION, CONCENTRATE |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20100301 |
| Marketing Category Name | ANDA |
| Labeler Name | General Injectables & Vaccines, Inc. |
| Substance Name | AMIODARONE HYDROCHLORIDE |
| Strength Number | 50 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Antiarrhythmic [EPC] |
