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NDC 42291-0717-30 Ropinirole Hydrochloride 12 mg/1 Details
Ropinirole Hydrochloride 12 mg/1
Ropinirole Hydrochloride is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by AvKARE. The primary component is ROPINIROLE HYDROCHLORIDE.
MedlinePlus Drug Summary
Ropinirole 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. Ropinirole is also used to treat restless legs syndrome (RLS or Ekbom syndrome; 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). Ropinirole 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: 42291-0717-30Last Updated: 04/07/2024
MedLinePlus Full Drug Details: Ropinirole
Product Information
| NDC | 42291-0717 |
|---|---|
| Product ID | 42291-717_2b70539d-b409-4570-a189-4ad9880f4581 |
| Associated GPIs | |
| GCN Sequence Number | 064594 |
| GCN Sequence Number Description | ropinirole HCl TAB ER 24H 12 MG ORAL |
| HIC3 | H6A |
| HIC3 Description | ANTIPARKINSONISM DRUGS,OTHER |
| GCN | 15738 |
| HICL Sequence Number | 012182 |
| HICL Sequence Number Description | ROPINIROLE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Ropinirole Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ropinirole Hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 12 |
| Active Ingredient Units | mg/1 |
| Substance Name | ROPINIROLE HYDROCHLORIDE |
| Labeler Name | AvKARE |
| Pharmaceutical Class | Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090869 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42291-0717-30 (42291071730)
| NDC Package Code | 42291-717-30 |
|---|---|
| Billing NDC | 42291071730 |
| Package | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-717-30) |
| Marketing Start Date | 2023-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |