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
ANDA090135
Sponsor
Glenmark Pharmaceuticals Inc., USA
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).