NDC 0597-0191
Mirapex
Pramipexole Dihydrochloride
Mirapex is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Pramipexole Dihydrochloride.
| Product ID | 0597-0191_9db9830c-e088-f669-99ad-611ca38ab2ab |
| NDC | 0597-0191 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Mirapex |
| Generic Name | Pramipexole Dihydrochloride |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2004-01-01 |
| Marketing End Date | 2020-04-30 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020667 |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
| Active Ingredient Strength | 2 mg/1 |
| Pharm Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |
| NDC Exclude Flag | N |
Packaging
NDC 0597-0191-90
90 TABLET in 1 BOTTLE (0597-0191-90)
| Marketing Start Date | 2004-01-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0597-0191-90 [00597019190]
Mirapex TABLET
| Marketing Category | NDA |
| Application Number | NDA020667 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2004-01-01 |
| Marketing End Date | 2020-04-30 |
NDC 0597-0191-61 [00597019161]
Mirapex TABLET
| Marketing Category | NDA |
| Application Number | NDA020667 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2004-01-01 |
| Marketing End Date | 2019-10-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE | 1.5 mg/1 |
OpenFDA Data
| SPL SET ID: | 688fa4d7-de12-4930-8bc5-0169297c1da6 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Dopamine Agonists [MoA]
- Nonergot Dopamine Agonist [EPC]
NDC Crossover Matching brand name "Mirapex" or generic name "Pramipexole Dihydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0597-0101 | Mirapex | pramipexole dihydrochloride |
| 0597-0109 | Mirapex | pramipexole dihydrochloride |
| 0597-0113 | Mirapex | pramipexole dihydrochloride |
| 0597-0115 | Mirapex | pramipexole dihydrochloride |
| 0597-0116 | Mirapex | pramipexole dihydrochloride |
| 0597-0183 | Mirapex | pramipexole dihydrochloride |
| 0597-0184 | Mirapex | pramipexole dihydrochloride |
| 0597-0185 | Mirapex | pramipexole dihydrochloride |
| 0597-0190 | Mirapex | pramipexole dihydrochloride |
| 0597-0191 | Mirapex | pramipexole dihydrochloride |
| 0597-0285 | Mirapex | pramipexole dihydrochloride |
| 21695-867 | Mirapex | Mirapex |
Trademark Results [Mirapex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MIRAPEX 75027783 2062274 Live/Registered |
BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG 1995-12-04 |
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