FDA.reportPublic FDA data

Ropinirole

Product NDC
0228-3661
11-digit product format
002283661
Labeler code
0228
Product ID
0228-3661_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
12 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 HYDROCHLORIDE12 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
0228-3661-03Ropinirole30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-3661ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]19Current NDC, Legacy NDC, 1 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
0228-3661-030022836610330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3661-03) 2012-08-230000-00-00NoNoCurrent