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NDC 00781-5788-31 ropinirole 12 mg/1 Details
ropinirole 12 mg/1
ropinirole is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc. 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: 00781-5788-31Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ropinirole
Product Information
| NDC | 00781-5788 |
|---|---|
| Product ID | 0781-5788_d3bd26df-86a8-405a-ba67-5702cd8e089d |
| Associated GPIs | 73203070107550 |
| 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 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ropinirole |
| 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 | Sandoz Inc |
| Pharmaceutical Class | Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201047 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00781-5788-31 (00781578831)
| NDC Package Code | 0781-5788-31 |
|---|---|
| Billing NDC | 00781578831 |
| Package | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5788-31) |
| Marketing Start Date | 2012-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |