FDA.reportPublic FDA data

ropinirole

Product NDC
71335-1188
11-digit product format
713351188
Labeler code
71335
Product ID
71335-1188_cb378fb5-6dca-43e9-83bc-3c54eb9c1af7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204022
Marketing category
ANDA
Marketing start
2018-10-17
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.5 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 HYDROCHLORIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312846

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
71335-1188-1ropinirole30 in 1 BOTTLETABLET, FILM COATED30103
71335-1188-2ropinirole60 in 1 BOTTLETABLET, FILM COATED60103
71335-1188-3ropinirole90 in 1 BOTTLETABLET, FILM COATED90103
71335-1188-4ropinirole28 in 1 BOTTLETABLET, FILM COATED28103
71335-1188-5ropinirole100 in 1 BOTTLETABLET, FILM COATED100103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1188ROPINIROLE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20241116_cb378fb5-6dca-43e9-83bc-3c54eb9c1af7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312846rOPINIRole HCl 0.5 MG Oral TabletPSNcb378fb5-6dca-43e9-83bc-3c54eb9c1af7103
312846ropinirole 0.5 MG Oral TabletSCDcb378fb5-6dca-43e9-83bc-3c54eb9c1af7103
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSYcb378fb5-6dca-43e9-83bc-3c54eb9c1af7103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1188-17133511880130 TABLET, FILM COATED in 1 BOTTLE (71335-1188-1) 2021-03-050000-00-00NoNoCurrent
71335-1188-27133511880260 TABLET, FILM COATED in 1 BOTTLE (71335-1188-2) 2019-04-120000-00-00NoNoCurrent
71335-1188-37133511880390 TABLET, FILM COATED in 1 BOTTLE (71335-1188-3) 2024-10-310000-00-00NoNoCurrent
71335-1188-47133511880428 TABLET, FILM COATED in 1 BOTTLE (71335-1188-4) 2024-10-310000-00-00NoNoCurrent
71335-1188-571335118805100 TABLET, FILM COATED in 1 BOTTLE (71335-1188-5) 2024-10-310000-00-00NoNoCurrent