ropinirole hydrochloride

FDA Drug Profile — ropinirole hydrochloride, ROPINIROLE HYDROCHLORIDE

ropinirole hydrochloride is listed in the FDA National Drug Code directory with 32 NDC codes, marketed under brand names including ropinirole hydrochloride, ROPINIROLE HYDROCHLORIDE. Available dosage forms: tablet, film coated, tablet, film coated, extended release.

Drug Details

Generic Name
ropinirole hydrochloride
Brand Names
ropinirole hydrochloride, ROPINIROLE HYDROCHLORIDE
Application Number
ANDA078110
Sponsor
A-S Medication Solutions
NDC Codes
32
Dosage Forms
TABLET, FILM COATED, TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients
ROPINIROLE HYDROCHLORIDE

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).