| Product NDC: | 16590-409 |
| Proprietary Name: | PRAMIPEXOLE DIHYDROCHLORIDE |
| 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: | 16590-409 |
| Labeler Name: | STAT RX USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA077724 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20100101 |
| Package NDC: | 16590-409-40 |
| Package Description: | 40 TABLET in 1 BOTTLE (16590-409-40) |
| NDC Code | 16590-409-40 |
| Proprietary Name | PRAMIPEXOLE DIHYDROCHLORIDE |
| Package Description | 40 TABLET in 1 BOTTLE (16590-409-40) |
| Product NDC | 16590-409 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | PRAMIPEXOLE DIHYDROCHLORIDE |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20100101 |
| Marketing Category Name | ANDA |
| Labeler Name | STAT RX USA LLC |
| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
| Strength Number | .5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |