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Mirapex
Mirapex - 0597-0116-30 - (pramipexole dihydrochloride)
Drug Information of Mirapex
| Product NDC: | 0597-0116 |
| Proprietary Name: | Mirapex |
| Non Proprietary Name: | pramipexole dihydrochloride |
| Active Ingredient(s): | 4.5 mg/1 & nbsp; pramipexole dihydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Mirapex
| Product NDC: | 0597-0116 |
| Labeler Name: | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022421 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100222 |
Package Information of Mirapex
| Package NDC: | 0597-0116-30 |
| Package Description: | 1 BOTTLE, PLASTIC in 1 CARTON (0597-0116-30) > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
NDC Information of Mirapex
| NDC Code | 0597-0116-30 |
| Proprietary Name | Mirapex |
| Package Description | 1 BOTTLE, PLASTIC in 1 CARTON (0597-0116-30) > 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC |
| Product NDC | 0597-0116 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | pramipexole dihydrochloride |
| Dosage Form Name | TABLET, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20100222 |
| Marketing Category Name | NDA |
| Labeler Name | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
| Strength Number | 4.5 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |
