FDA.reportPublic FDA data

ropinirole

Product NDC
71335-1231
11-digit product format
713351231
Labeler code
71335
Product ID
71335-1231_1c85c85d-fe34-4795-96c2-ad2fbf428a7a
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
.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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312845

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
71335-1231-1ropinirole30 in 1 BOTTLETABLET, FILM COATED30102
71335-1231-2ropinirole60 in 1 BOTTLETABLET, FILM COATED60102
71335-1231-3ropinirole28 in 1 BOTTLETABLET, FILM COATED28102
71335-1231-4ropinirole100 in 1 BOTTLETABLET, FILM COATED100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1231ROPINIROLE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20241120_8ebaa083-9f72-4e43-a4c4-36e3e7b5d5f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN8ebaa083-9f72-4e43-a4c4-36e3e7b5d5f2102
312845ropinirole 0.25 MG Oral TabletSCD8ebaa083-9f72-4e43-a4c4-36e3e7b5d5f2102
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY8ebaa083-9f72-4e43-a4c4-36e3e7b5d5f2102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1231-17133512310130 TABLET, FILM COATED in 1 BOTTLE (71335-1231-1) 2019-05-240000-00-00NoNoCurrent
71335-1231-27133512310260 TABLET, FILM COATED in 1 BOTTLE (71335-1231-2) 2024-10-310000-00-00NoNoCurrent
71335-1231-37133512310328 TABLET, FILM COATED in 1 BOTTLE (71335-1231-3) 2024-10-310000-00-00NoNoCurrent
71335-1231-471335123104100 TABLET, FILM COATED in 1 BOTTLE (71335-1231-4) 2024-10-31NoNoHistorical