FDA.reportPublic FDA data

ROPINIROLE HYDROCHLORIDE

Product NDC
42291-716
11-digit product format
422910716
Labeler code
42291
Product ID
42291-716_2b47ad1c-e1cb-7b8b-e063-6394a90aee3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA090869
Marketing category
ANDA
Marketing start
2013-09-13
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 HYDROCHLORIDE
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
42291-716-30ROPINIROLE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE306
42291-716-90ROPINIROLE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-716-90EA - Each42291-71609f86cfb-bdbe-4146-b9e0-faa06946369012013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
42291-716ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [AVKARE]6Current NDC, 2 package rows20250112_abd344d9-7635-62a2-d4e1-38fc46937397.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
42291-716-304229107163030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-716-30) 2023-11-01NoNoHistorical
42291-716-904229107169090 in 1 BOTTLEHistorical