Product NDC: | 54868-5186 |
Proprietary Name: | PACERONE |
Non Proprietary Name: | amiodarone hydrochloride |
Active Ingredient(s): | 200 mg/1 & nbsp; amiodarone hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54868-5186 |
Labeler Name: | Physicians Total Care, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA075135 |
Marketing Category: | ANDA |
Start Marketing Date: | 20081022 |
Package NDC: | 54868-5186-0 |
Package Description: | 30 TABLET in 1 BOTTLE, PLASTIC (54868-5186-0) |
NDC Code | 54868-5186-0 |
Proprietary Name | PACERONE |
Package Description | 30 TABLET in 1 BOTTLE, PLASTIC (54868-5186-0) |
Product NDC | 54868-5186 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | amiodarone hydrochloride |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20081022 |
Marketing Category Name | ANDA |
Labeler Name | Physicians Total Care, Inc. |
Substance Name | AMIODARONE HYDROCHLORIDE |
Strength Number | 200 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Antiarrhythmic [EPC] |