Product NDC: | 63323-616 |
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: | 63323-616 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA075761 |
Marketing Category: | ANDA |
Start Marketing Date: | 20030128 |
Package NDC: | 63323-616-09 |
Package Description: | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-09) > 9 mL in 1 VIAL, SINGLE-DOSE |
NDC Code | 63323-616-09 |
Proprietary Name | Amiodarone Hydrochloride |
Package Description | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-09) > 9 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 63323-616 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | AMIODARONE HYDROCHLORIDE |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20030128 |
Marketing Category Name | ANDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | AMIODARONE HYDROCHLORIDE |
Strength Number | 50 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Antiarrhythmic [EPC] |