 
                        | Product NDC: | 54868-5412 | 
| Proprietary Name: | MIRAPEX | 
| Non Proprietary Name: | pramipexole dihydrochloride | 
| Active Ingredient(s): | .5 mg/1 & nbsp; pramipexole dihydrochloride | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 54868-5412 | 
| Labeler Name: | Physicians Total Care, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | NDA020667 | 
| Marketing Category: | NDA | 
| Start Marketing Date: | 20050912 | 
| Package NDC: | 54868-5412-1 | 
| Package Description: | 30 TABLET in 1 BOTTLE, PLASTIC (54868-5412-1) | 
| NDC Code | 54868-5412-1 | 
| Proprietary Name | MIRAPEX | 
| Package Description | 30 TABLET in 1 BOTTLE, PLASTIC (54868-5412-1) | 
| Product NDC | 54868-5412 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | pramipexole dihydrochloride | 
| Dosage Form Name | TABLET | 
| Route Name | ORAL | 
| Start Marketing Date | 20050912 | 
| Marketing Category Name | NDA | 
| Labeler Name | Physicians Total Care, Inc. | 
| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE | 
| Strength Number | .5 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |