FDA.reportPublic FDA data

ropinirole

Product NDC
71335-0447
11-digit product format
713350447
Labeler code
71335
Product ID
71335-0447_e68abb6b-d042-434a-b51e-86be84e3ae7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090135
Marketing category
ANDA
Marketing start
2010-02-25
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 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 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
71335-0447-1ropinirole30 in 1 BOTTLETABLET, FILM COATED30101
71335-0447-2ropinirole28 in 1 BOTTLETABLET, FILM COATED28101
71335-0447-3ropinirole90 in 1 BOTTLETABLET, FILM COATED90101
71335-0447-4ropinirole60 in 1 BOTTLETABLET, FILM COATED60101
71335-0447-5ropinirole100 in 1 BOTTLETABLET, FILM COATED100101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0447ROPINIROLE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, Legacy NDC, 5 package rows20240526_e32ef7a6-b4b6-4a22-a2ed-722255b486b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314208rOPINIRole HCl 1 MG Oral TabletPSNe32ef7a6-b4b6-4a22-a2ed-722255b486b4101
314208ropinirole 1 MG Oral TabletSCDe32ef7a6-b4b6-4a22-a2ed-722255b486b4101
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSYe32ef7a6-b4b6-4a22-a2ed-722255b486b4101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-0447-17133504470130 TABLET, FILM COATED in 1 BOTTLE (71335-0447-1) 2024-05-24NoNoCurrent
71335-0447-27133504470228 TABLET, FILM COATED in 1 BOTTLE (71335-0447-2) 2024-05-24NoNoCurrent
71335-0447-37133504470390 TABLET, FILM COATED in 1 BOTTLE (71335-0447-3) 2024-05-24NoNoCurrent
71335-0447-47133504470460 TABLET, FILM COATED in 1 BOTTLE (71335-0447-4) 2024-05-24NoNoCurrent
71335-0447-571335044705100 TABLET, FILM COATED in 1 BOTTLE (71335-0447-5) 2024-05-24NoNoCurrent