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NDC 68462-0330-11 Pramipexole dihydrochloride 0.125 mg/1 Details
Pramipexole dihydrochloride 0.125 mg/1
Pramipexole dihydrochloride is a ORAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Glenmark Pharmaceuticals Inc., USA. The primary component is PRAMIPEXOLE DIHYDROCHLORIDE.
MedlinePlus Drug Summary
Pramipexole is used alone or with other medications to treat the symptoms of Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance), including shaking of parts of the body, stiffness, slowed movements, and problems with balance. Pramipexole is also used to treat restless legs syndrome (RLS; a condition that causes discomfort in the legs and a strong urge to move the legs, especially at night and when sitting or lying down). Pramipexole is in a class of medications called dopamine agonists. It works by acting in place of dopamine, a natural substance in the brain that is needed to control movement.
Related Packages: 68462-0330-11Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pramipexole
Product Information
| NDC | 68462-0330 |
|---|---|
| Product ID | 68462-330_d625660d-78d1-4e40-bc41-1f1f74e56744 |
| Associated GPIs | 73203060100305 |
| GCN Sequence Number | 031781 |
| GCN Sequence Number Description | pramipexole di-HCl TABLET 0.125 MG ORAL |
| HIC3 | H6A |
| HIC3 Description | ANTIPARKINSONISM DRUGS,OTHER |
| GCN | 19873 |
| HICL Sequence Number | 013455 |
| HICL Sequence Number Description | PRAMIPEXOLE DI-HCL |
| Brand/Generic | Generic |
| Proprietary Name | Pramipexole dihydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Pramipexole dihydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 0.125 |
| Active Ingredient Units | mg/1 |
| Substance Name | PRAMIPEXOLE DIHYDROCHLORIDE |
| Labeler Name | Glenmark Pharmaceuticals Inc., USA |
| Pharmaceutical Class | Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090781 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 68462-0330-11 (68462033011)
| NDC Package Code | 68462-330-11 |
|---|---|
| Billing NDC | 68462033011 |
| Package | 10 BLISTER PACK in 1 CARTON (68462-330-11) / 10 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2010-10-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |