PRAMIPEXOLE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Pramipexole Dihydrochloride.
| Product ID | 50090-3009_0915ce06-2d76-408e-8ead-31d0bdb56ee6 |
| NDC | 50090-3009 |
| Product Type | Human Prescription Drug |
| Proprietary Name | PRAMIPEXOLE |
| Generic Name | Pramipexole |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2015-08-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA203855 |
| Labeler Name | A-S Medication Solutions |
| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
| Active Ingredient Strength | 1 mg/1 |
| Pharm Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2017-05-10 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA203855 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-05-10 |
| Marketing End Date | 2018-06-30 |
| Ingredient | Strength |
|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | .5 mg/1 |
| SPL SET ID: | 172f1774-b0da-4af1-b500-527bb4278d7e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 31722-906 | PRAMIPEXOLE | PRAMIPEXOLE |
| 31722-907 | PRAMIPEXOLE | PRAMIPEXOLE |
| 31722-908 | PRAMIPEXOLE | PRAMIPEXOLE |
| 31722-909 | PRAMIPEXOLE | PRAMIPEXOLE |
| 31722-910 | PRAMIPEXOLE | PRAMIPEXOLE |
| 31722-911 | PRAMIPEXOLE | PRAMIPEXOLE |
| 50090-3009 | PRAMIPEXOLE | PRAMIPEXOLE |
| 10370-251 | Pramipexole Dihydrochloride | Pramipexole |
| 10370-252 | Pramipexole Dihydrochloride | Pramipexole |
| 10370-253 | Pramipexole Dihydrochloride | Pramipexole |
| 10370-254 | Pramipexole Dihydrochloride | Pramipexole |
| 10370-255 | Pramipexole Dihydrochloride | Pramipexole |
| 10370-305 | Pramipexole Dihydrochloride | Pramipexole |
| 10370-306 | Pramipexole Dihydrochloride | Pramipexole |
| 42291-557 | Pramipexole Dihydrochloride | Pramipexole |