| NDC Code | 0597-0109-30 |
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| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (0597-0109-30) / 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
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| Product NDC | 0597-0109 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Mirapex |
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| Proprietary Name Suffix | Er |
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| Non-Proprietary Name | Pramipexole Dihydrochloride |
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| Dosage Form | TABLET, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20100222 |
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| End Marketing Date | 20240731 |
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| Marketing Category Name | NDA |
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| Application Number | NDA022421 |
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| Manufacturer | Boehringer Ingelheim Pharmaceuticals, Inc. |
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| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
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| Strength | .375 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC] |
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