Skip to content
LookupMeds

Active ingredient

Ropinirole

149 finished FDA listings contain Ropinirole as their only active ingredient.

See all listingsCompare with another medication

FDA NDC Directory

Ingredient names as written by FDA
ROPINIROLE, ROPINIROLE HYDROCHLORIDE
Dosage forms
Tablet, Extended Release, Tablet, Film Coated, Tablet, Film Coated, Extended Release
Routes
Oral
Manufacturers / labelers
27
Strengths listed
.25 mg/1 · .5 mg/1 · 1 mg/1 · 12 mg/1 · 2 mg/1 · 3 mg/1 · 4 mg/1 · 5 mg/1 · 6 mg/1 · 8 mg/1

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 72302

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 078110PRINSTON INC2008-05-0527
ANDA 090135GLENMARK PHARMS LTD2010-02-2516
ANDA 090429ALEMBIC LTD2010-03-2426
ANDA 079165MLV2012-02-077
ANDA 090869ACTAVIS ELIZABETH2012-05-1710
ANDA 201576DR REDDYS LABS LTD2012-06-065
ANDA 079229ORBION PHARMS2012-11-2819
ANDA 202786ALEMBIC2013-04-2210
ANDA 204022ACCORD HLTHCARE2017-02-2814
ANDA 204413PRINSTON INC2022-05-115
ANDA 217862ELITE LABS INC2025-11-1010

Official labeling on DailyMed

Showing the 12 most recent of 59 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.