FDA.reportPublic FDA data

ROPINIROLE

Substance profile for UNII 030PYR8953, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for ROPINIROLE
Structure render from PubChem CID 5095

Substance Identity#

UNII
030PYR8953
Preferred term
ROPINIROLE
Registry number
91374-21-9
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C16H24N2O
Chemical structure for ROPINIROLE
Structure render from PubChem CID 5095

Chemical And Database Identifiers#

InChIKey
UHSKFQJFRQCDBE-UHFFFAOYSA-N
SMILES
CCCN(CCC)CCC1=C2CC(=O)NC2=CC=C1
RxCUI
72302
PubChem
5095
NCIt
C61931
INN ID
6436

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound5095pubchem.ncbi.nlm.nih.gov/compound/5095
PubChem InChIKey SearchUHSKFQJFRQCDBE-UHFFFAOYSA-Npubchem.ncbi.nlm.nih.gov/#query=UHSKFQJFRQCDBE-UHFFFAOYSA-N
RxNorm72302mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=72302
NCI ThesaurusC61931ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C61931
FDA Substance Registration System030PYR8953precision.fda.gov/uniisearch/srs/unii/030PYR8953

DailyMed Socrata Ingredients#

DailyMed label, SPL version table
DailyMed labelSPL version
Ropinirole Hydrochloride Tablets Rx only PRESCRIBING INFORMATION Patient Information Included1
rOPINIRole Tablets USP1
Ropinirole Hydrochloride Tablets Rx only PRESCRIBING INFORMATION Patient Information Included1000
Ropinirole Hydrochloride Tablets Rx only PRESCRIBING INFORMATION Patient Information Included1000
Ropinirole Hydrochloride Tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Rx only7
Ropinirole Hydrochloride Tablets Rx only PRESCRIBING INFORMATION Patient Information Included2
rOPINIRole Tablets USP3
Ropinirole Tablets, USP2
Ropinirole Hydrochloride Tablets12
These highlights do not include all the information needed to use ROPINIROLE extended-release tablets safely and effectively. See full prescribing information for ROPINIROLE extended-release tablets. ROPINIROLE extended-release tablets for oral use Initial U.S. Approval: 19971
These highlights do not include all the information needed to use REQUIP XL safely and effectively. See full prescribing information for REQUIP XL. REQUIP XL (ropinirole extended-release tablets) Initial U.S. Approval: 19975
Ropinirole Hydrochloride Tablets2
Ropinirole Hydrochloride Tablets1
a543b4fb-186a-40f4-8c88-861b7db2b3e91
Ropinirole Hydrochloride Tablets 0.25 mg, 1 mg and 5 mg Rx only1
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
REQUIP (ROPINIROLE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ROPINIROLE HYDROCHLORIDE (ROPINIROLE) TABLET [MYLAN PHARMACEUTICALS INC.]14
ROPINIROLE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]14
REQUIP XL (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]13
ROPINIROLE 2 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 4 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 6 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 8 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE ROPINIROLE 12 MG (ROPINIROLE) TABLET, FILM COATED, EXTENDED RELEASE [TRIGEN LABORATORIES, INC.]10
REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]9
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]7
ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
REQUIP (ROPINIROLE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]5
ROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]3
ROPINIROLE TABLET, FILM COATED [APOTEX CORP.]3
ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]3
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH]1
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]1
ROPINIROLE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1