FDA.reportPublic FDA data

Ropinirole

Product NDC
0228-3660
11-digit product format
002283660
Labeler code
0228
Product ID
0228-3660_3499549d-d3ad-4636-8234-2539c0fbfac1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA090869
Marketing category
ANDA
Marketing start
2012-08-23
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
8 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ropinirole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui799054, 799055, 799056, 824959, 848582

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc920868-8845-b908-7ca8-0dee3e345af5Product name220230123
e24bc1b4-1e16-908e-3d09-29da3ca2fb1fProduct name220170517

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-3660-03Ropinirole30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3020
0228-3660-09Ropinirole90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-3660-03EA - Each0228-3660b40d4c8b-faf0-42d9-8bb2-2f5275f235b112012-07-24
0228-3660-09EA - Each0228-3660fc631736-ecc7-41c5-8179-1af32a28d2d912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
TALCINACTIVE INGREDIENT7SEV7J4R1UROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
TRIACETININACTIVE INGREDIENTXHX3C3X673ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]9
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Castor OilINACTIVE INGREDIENTD5340Y2I9GROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Fd&c Blue No. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
MaltodextrinINACTIVE INGREDIENT7CVR7L4A2DROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
PolydextroseINACTIVE INGREDIENTVH2XOU12IEROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Polyvinyl AlcoholINACTIVE INGREDIENT532B59J990ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
TalcINACTIVE INGREDIENT7SEV7J4R1UROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1
TriacetinINACTIVE INGREDIENTXHX3C3X673ROPINIROLE HYDROCHLORIDE (ROPINIROLE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AVKARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-3660ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 2 package rows20241105_300946bf-2f83-471d-868d-9820b65c52bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824959rOPINIRole 12 MG 24HR Extended Release Oral TabletPSN300946bf-2f83-471d-868d-9820b65c52bb20
799055rOPINIRole 2 MG 24HR Extended Release Oral TabletPSN300946bf-2f83-471d-868d-9820b65c52bb20
799056rOPINIRole 4 MG 24HR Extended Release Oral TabletPSN300946bf-2f83-471d-868d-9820b65c52bb20
848582rOPINIRole 6 MG 24HR Extended Release Oral TabletPSN300946bf-2f83-471d-868d-9820b65c52bb20
799054rOPINIRole 8 MG 24HR Extended Release Oral TabletPSN300946bf-2f83-471d-868d-9820b65c52bb20
82495924 HR ropinirole 12 MG Extended Release Oral TabletSCD300946bf-2f83-471d-868d-9820b65c52bb20
79905524 HR ropinirole 2 MG Extended Release Oral TabletSCD300946bf-2f83-471d-868d-9820b65c52bb20
79905624 HR ropinirole 4 MG Extended Release Oral TabletSCD300946bf-2f83-471d-868d-9820b65c52bb20
84858224 HR ropinirole 6 MG Extended Release Oral TabletSCD300946bf-2f83-471d-868d-9820b65c52bb20
79905424 HR ropinirole 8 MG Extended Release Oral TabletSCD300946bf-2f83-471d-868d-9820b65c52bb20
824959ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral TabletSY300946bf-2f83-471d-868d-9820b65c52bb20
824959ropinirole 12 MG 24 HR Extended Release Oral TabletSY300946bf-2f83-471d-868d-9820b65c52bb20
799055ropinirole 2 MG (as ropinirole hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY300946bf-2f83-471d-868d-9820b65c52bb20
799055ropinirole 2 MG 24 HR Extended Release Oral TabletSY300946bf-2f83-471d-868d-9820b65c52bb20
799056ropinirole 4 MG (as ropinirole hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY300946bf-2f83-471d-868d-9820b65c52bb20
799056ropinirole 4 MG 24 HR Extended Release Oral TabletSY300946bf-2f83-471d-868d-9820b65c52bb20
848582ropinirole 6 MG (ropinirole hydrochloride 6.84 MG) 24 HR Extended Release Oral TabletSY300946bf-2f83-471d-868d-9820b65c52bb20
848582ropinirole 6 MG 24 HR Extended Release Oral TabletSY300946bf-2f83-471d-868d-9820b65c52bb20
799054ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral TabletSY300946bf-2f83-471d-868d-9820b65c52bb20
799054ropinirole 8 MG 24 HR Extended Release Oral TabletSY300946bf-2f83-471d-868d-9820b65c52bb20
824959rOPINIRole 12 MG 24HR Extended Release Oral TabletPSNabd344d9-7635-62a2-d4e1-38fc469373976
799055rOPINIRole 2 MG 24HR Extended Release Oral TabletPSNabd344d9-7635-62a2-d4e1-38fc469373976
799056rOPINIRole 4 MG 24HR Extended Release Oral TabletPSNabd344d9-7635-62a2-d4e1-38fc469373976
848582rOPINIRole 6 MG 24HR Extended Release Oral TabletPSNabd344d9-7635-62a2-d4e1-38fc469373976
799054rOPINIRole 8 MG 24HR Extended Release Oral TabletPSNabd344d9-7635-62a2-d4e1-38fc469373976
82495924 HR ropinirole 12 MG Extended Release Oral TabletSCDabd344d9-7635-62a2-d4e1-38fc469373976
79905524 HR ropinirole 2 MG Extended Release Oral TabletSCDabd344d9-7635-62a2-d4e1-38fc469373976
79905624 HR ropinirole 4 MG Extended Release Oral TabletSCDabd344d9-7635-62a2-d4e1-38fc469373976
84858224 HR ropinirole 6 MG Extended Release Oral TabletSCDabd344d9-7635-62a2-d4e1-38fc469373976
79905424 HR ropinirole 8 MG Extended Release Oral TabletSCDabd344d9-7635-62a2-d4e1-38fc469373976
824959ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral TabletSYabd344d9-7635-62a2-d4e1-38fc469373976
824959ropinirole 12 MG 24 HR Extended Release Oral TabletSYabd344d9-7635-62a2-d4e1-38fc469373976
799055ropinirole 2 MG (as ropinirole hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSYabd344d9-7635-62a2-d4e1-38fc469373976
799055ropinirole 2 MG 24 HR Extended Release Oral TabletSYabd344d9-7635-62a2-d4e1-38fc469373976
799056ropinirole 4 MG (as ropinirole hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSYabd344d9-7635-62a2-d4e1-38fc469373976
799056ropinirole 4 MG 24 HR Extended Release Oral TabletSYabd344d9-7635-62a2-d4e1-38fc469373976
848582ropinirole 6 MG (ropinirole hydrochloride 6.84 MG) 24 HR Extended Release Oral TabletSYabd344d9-7635-62a2-d4e1-38fc469373976
848582ropinirole 6 MG 24 HR Extended Release Oral TabletSYabd344d9-7635-62a2-d4e1-38fc469373976
799054ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral TabletSYabd344d9-7635-62a2-d4e1-38fc469373976
799054ropinirole 8 MG 24 HR Extended Release Oral TabletSYabd344d9-7635-62a2-d4e1-38fc469373976

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0228-3660-030022836600330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3660-03) 2012-08-230000-00-00NoNoCurrent
0228-3660-090022836600990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3660-09) 2012-08-230000-00-00NoNoCurrent