Product NDC: | 0245-0145 |
Proprietary Name: | Pacerone |
Non Proprietary Name: | Amiodarone Hydrochloride |
Active Ingredient(s): | 400 mg/1 & nbsp; Amiodarone Hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0245-0145 |
Labeler Name: | Upsher-Smith Laboratories, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA075135 |
Marketing Category: | ANDA |
Start Marketing Date: | 20000630 |
Package NDC: | 0245-0145-15 |
Package Description: | 500 TABLET in 1 BOTTLE (0245-0145-15) |
NDC Code | 0245-0145-15 |
Proprietary Name | Pacerone |
Package Description | 500 TABLET in 1 BOTTLE (0245-0145-15) |
Product NDC | 0245-0145 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Amiodarone Hydrochloride |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20000630 |
Marketing Category Name | ANDA |
Labeler Name | Upsher-Smith Laboratories, Inc. |
Substance Name | AMIODARONE HYDROCHLORIDE |
Strength Number | 400 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Antiarrhythmic [EPC] |