| NDC Code | 68382-476-77 |
| Package Description | 10 BLISTER PACK in 1 CARTON (68382-476-77) > 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-476-30) |
| Product NDC | 68382-476 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Pramipexole Dihydrochloride |
| Non-Proprietary Name | Pramipexole Dihydrochloride |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20180424 |
| Marketing Category Name | ANDA |
| Application Number | ANDA202891 |
| Manufacturer | Zydus Pharmaceuticals USA Inc. |
| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
| Strength | 1.5 |
| Strength Unit | mg/1 |
| Pharmacy Classes | Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC] |