ropinirole

Product NDC
50090-4804
11-digit product format
500904804
Labeler code
50090
Product ID
50090-4804_036f14fd-412a-4a69-9a20-db2701bffe57
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204022
Marketing category
ANDA
Marketing start
2018-10-17
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc920868-8845-b908-7ca8-0dee3e345af5Product name220230123
e24bc1b4-1e16-908e-3d09-29da3ca2fb1fProduct name220170517

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4804-0ropinirole1 in 1 CARTONTABLET, FILM COATED11
50090-4804-0ropinirole33 in 1 BLISTER PACKTABLET, FILM COATED331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4804ROPINIROLE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20221206_88b5baf6-bf5c-4b87-8910-d72e26ba18ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN88b5baf6-bf5c-4b87-8910-d72e26ba18ee1
312845ropinirole 0.25 MG Oral TabletSCD88b5baf6-bf5c-4b87-8910-d72e26ba18ee1
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY88b5baf6-bf5c-4b87-8910-d72e26ba18ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4804-0500904804001 BLISTER PACK in 1 CARTON (50090-4804-0) > 33 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2019-12-200000-00-00NoNoCurrent