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 Compound5095https://pubchem.ncbi.nlm.nih.gov/compound/5095
PubChem InChIKey SearchUHSKFQJFRQCDBE-UHFFFAOYSA-Nhttps://pubchem.ncbi.nlm.nih.gov/#query=UHSKFQJFRQCDBE-UHFFFAOYSA-N
RxNorm72302https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=72302
NCI ThesaurusC61931https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C61931
FDA Substance Registration System030PYR8953https://precision.fda.gov/uniisearch/srs/unii/030PYR8953

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLEACTIVE MOIETY030PYR8953Ropinirole Hydrochloride Tablets Rx only PRESCRIBING INFORMATION Patient Information Included1
ROPINIROLEACTIVE MOIETY030PYR8953rOPINIRole Tablets USP1
ROPINIROLEACTIVE MOIETY030PYR8953Ropinirole Hydrochloride Tablets 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg Rx only7
ROPINIROLEACTIVE MOIETY030PYR8953Ropinirole Hydrochloride Tablets Rx only PRESCRIBING INFORMATION Patient Information Included2
ROPINIROLEACTIVE MOIETY030PYR8953rOPINIRole Tablets USP3
ROPINIROLEACTIVE MOIETY030PYR8953Ropinirole Tablets, USP2
ROPINIROLEACTIVE MOIETY030PYR8953These 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
ROPINIROLEACTIVE MOIETY030PYR8953These 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
ROPINIROLEACTIVE MOIETY030PYR8953Ropinirole Hydrochloride Tablets2
ROPINIROLEACTIVE MOIETY030PYR8953Ropinirole Hydrochloride Tablets1
ROPINIROLEACTIVE MOIETY030PYR8953a543b4fb-186a-40f4-8c88-861b7db2b3e91
ROPINIROLEACTIVE MOIETY030PYR8953Ropinirole Hydrochloride Tablets 0.25 mg, 1 mg and 5 mg Rx only1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
ROPINIROLEACTIVE MOIETY030PYR8953REQUIP (ROPINIROLE) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE (ROPINIROLE) TABLET [MYLAN PHARMACEUTICALS INC.]14
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC.]14
ROPINIROLEACTIVE MOIETY030PYR8953REQUIP XL (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]13
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]12
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE 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
ROPINIROLEACTIVE MOIETY030PYR8953REQUIP (ROPINIROLE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]9
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WATSON LABORATORIES, INC.]7
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
ROPINIROLEACTIVE MOIETY030PYR8953REQUIP (ROPINIROLE) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]6
RopiniroleACTIVE MOIETY030PYR8953ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]5
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET [ROXANE LABORATORIES, INC]5
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]4
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]3
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]3
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET, FILM COATED [APOTEX CORP.]3
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]3
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]2
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT USA LLC.]2
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH]1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT USA LLC.]1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1