Product NDC: | 55390-097 |
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: | 55390-097 |
Labeler Name: | Bedford Laboratories |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA076018 |
Marketing Category: | ANDA |
Start Marketing Date: | 20071001 |
Package NDC: | 55390-097-10 |
Package Description: | 10 VIAL, SINGLE-USE in 1 BOX (55390-097-10) > 3 mL in 1 VIAL, SINGLE-USE |
NDC Code | 55390-097-10 |
Proprietary Name | Amiodarone Hydrochloride |
Package Description | 10 VIAL, SINGLE-USE in 1 BOX (55390-097-10) > 3 mL in 1 VIAL, SINGLE-USE |
Product NDC | 55390-097 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Amiodarone Hydrochloride |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20071001 |
Marketing Category Name | ANDA |
Labeler Name | Bedford Laboratories |
Substance Name | AMIODARONE HYDROCHLORIDE |
Strength Number | 50 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Antiarrhythmic [EPC] |