FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
71335-0587
11-digit product format
713350587
Labeler code
71335
Product ID
71335-0587_d88b1f49-8ea3-43fa-ae34-0cb10ca3a562
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078110
Marketing category
ANDA
Marketing start
2011-09-20
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.25 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 HYDROCHLORIDE.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312845, 312847, 314208

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
71335-0587-1ropinirole hydrochloride30 in 1 BOTTLETABLET, FILM COATED3010
71335-0587-2ropinirole hydrochloride60 in 1 BOTTLETABLET, FILM COATED6010
71335-0587-3ropinirole hydrochloride28 in 1 BOTTLETABLET, FILM COATED2810
71335-0587-4ropinirole hydrochloride100 in 1 BOTTLETABLET, FILM COATED10010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0587ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 4 package rows20231031_6c10444a-48da-469d-bf8f-1e6e0b7e15f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN6c10444a-48da-469d-bf8f-1e6e0b7e15f810
314208rOPINIRole HCl 1 MG Oral TabletPSN6c10444a-48da-469d-bf8f-1e6e0b7e15f810
312847rOPINIRole HCl 2 MG Oral TabletPSN6c10444a-48da-469d-bf8f-1e6e0b7e15f810
312845ropinirole 0.25 MG Oral TabletSCD6c10444a-48da-469d-bf8f-1e6e0b7e15f810
314208ropinirole 1 MG Oral TabletSCD6c10444a-48da-469d-bf8f-1e6e0b7e15f810
312847ropinirole 2 MG Oral TabletSCD6c10444a-48da-469d-bf8f-1e6e0b7e15f810
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY6c10444a-48da-469d-bf8f-1e6e0b7e15f810
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY6c10444a-48da-469d-bf8f-1e6e0b7e15f810
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY6c10444a-48da-469d-bf8f-1e6e0b7e15f810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0587-17133505870130 TABLET, FILM COATED in 1 BOTTLE (71335-0587-1) 2016-12-090000-00-00NoNoCurrent
71335-0587-27133505870260 TABLET, FILM COATED in 1 BOTTLE (71335-0587-2) 2016-12-090000-00-00NoNoCurrent
71335-0587-37133505870328 TABLET, FILM COATED in 1 BOTTLE (71335-0587-3) 2016-12-090000-00-00NoNoCurrent
71335-0587-471335058704100 TABLET, FILM COATED in 1 BOTTLE (71335-0587-4) 2016-12-09NoNoHistorical