FDA.reportPublic FDA data

ropinirole

Product NDC
71335-1982
11-digit product format
713351982
Labeler code
71335
Product ID
71335-1982_e07ffa15-dbae-469f-af38-4845489419b4
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
1 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 HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui314208

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
71335-1982-1ropinirole30 in 1 BOTTLETABLET, FILM COATED30103
71335-1982-2ropinirole28 in 1 BOTTLETABLET, FILM COATED28103
71335-1982-3ropinirole90 in 1 BOTTLETABLET, FILM COATED90103
71335-1982-4ropinirole60 in 1 BOTTLETABLET, FILM COATED60103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1982ROPINIROLE TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 4 package rows20241121_55bb5cf4-0e12-41b0-bc52-50b26fe408de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314208rOPINIRole HCl 1 MG Oral TabletPSN55bb5cf4-0e12-41b0-bc52-50b26fe408de103
314208ropinirole 1 MG Oral TabletSCD55bb5cf4-0e12-41b0-bc52-50b26fe408de103
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY55bb5cf4-0e12-41b0-bc52-50b26fe408de103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1982-17133519820130 TABLET, FILM COATED in 1 BOTTLE (71335-1982-1) 2021-11-020000-00-00NoNoCurrent
71335-1982-27133519820228 TABLET, FILM COATED in 1 BOTTLE (71335-1982-2) 2024-10-310000-00-00NoNoCurrent
71335-1982-37133519820390 TABLET, FILM COATED in 1 BOTTLE (71335-1982-3) 2024-10-310000-00-00NoNoCurrent
71335-1982-47133519820460 TABLET, FILM COATED in 1 BOTTLE (71335-1982-4) 2024-10-310000-00-00NoNoCurrent