ropinirole

FDA Drug Profile — ropinirole, Ropinirole, ROPINIROLE

ropinirole is listed in the FDA National Drug Code directory with 39 NDC codes, marketed under brand names including ropinirole, Ropinirole, ROPINIROLE. Available dosage forms: tablet, film coated, tablet, extended release.

Drug Details

Generic Name
ropinirole
Brand Names
ropinirole, Ropinirole, ROPINIROLE
Application Number
ANDA204022
Sponsor
A-S Medication Solutions
NDC Codes
39
Dosage Forms
TABLET, FILM COATED, TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
ROPINIROLE HYDROCHLORIDE, ROPINIROLE

Indications and Usage

1 INDICATIONS AND USAGE Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1 , 1.2 ) 1.1 Parkinson’s Disease Ropinirole tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).