FDA.reportPublic FDA data

Ropinirole

Product NDC
71335-2793
11-digit product format
713352793
Labeler code
71335
Product ID
71335-2793_3bb5d006-f98d-43e3-8884-14cb5c367db9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079229
Marketing category
ANDA
Marketing start
2022-09-15
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.25 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ropinirole
Listing expiration
2027-12-31

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
71335-2793-1Ropinirole30 in 1 BOTTLETABLET, FILM COATED30100
71335-2793-2Ropinirole60 in 1 BOTTLETABLET, FILM COATED60100
71335-2793-3Ropinirole28 in 1 BOTTLETABLET, FILM COATED28100
71335-2793-4Ropinirole100 in 1 BOTTLETABLET, FILM COATED100100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN245fc49d-609e-4431-b8fa-668b39d12ec2100
312845ropinirole 0.25 MG Oral TabletSCD245fc49d-609e-4431-b8fa-668b39d12ec2100
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY245fc49d-609e-4431-b8fa-668b39d12ec2100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2793-17133527930130 TABLET, FILM COATED in 1 BOTTLE (71335-2793-1) 2026-03-11NoNoHistorical
71335-2793-27133527930260 TABLET, FILM COATED in 1 BOTTLE (71335-2793-2) 2026-03-11NoNoHistorical
71335-2793-37133527930328 TABLET, FILM COATED in 1 BOTTLE (71335-2793-3) 2026-03-11NoNoHistorical
71335-2793-471335279304100 TABLET, FILM COATED in 1 BOTTLE (71335-2793-4) 2026-03-11NoNoHistorical