| Product NDC: | 0245-0144 |
| Proprietary Name: | Pacerone |
| Non Proprietary Name: | Amiodarone Hydrochloride |
| Active Ingredient(s): | 100 mg/1 & nbsp; Amiodarone Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0245-0144 |
| Labeler Name: | Upsher-Smith Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA075135 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110119 |
| Package NDC: | 0245-0144-30 |
| Package Description: | 1 BOTTLE in 1 CARTON (0245-0144-30) > 30 TABLET in 1 BOTTLE |
| NDC Code | 0245-0144-30 |
| Proprietary Name | Pacerone |
| Package Description | 1 BOTTLE in 1 CARTON (0245-0144-30) > 30 TABLET in 1 BOTTLE |
| Product NDC | 0245-0144 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Amiodarone Hydrochloride |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20110119 |
| Marketing Category Name | ANDA |
| Labeler Name | Upsher-Smith Laboratories, Inc. |
| Substance Name | AMIODARONE HYDROCHLORIDE |
| Strength Number | 100 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Antiarrhythmic [EPC] |