ropinirole

Product NDC
50436-0255
11-digit product format
504360255
Labeler code
50436
Product ID
50436-0255_97bf1311-2e5c-48b2-972a-f661d425b2de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA090135
Marketing category
ANDA
Marketing start
2010-02-25
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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
50436-0255-1ropinirole50 in 1 BOX, UNIT-DOSETABLET, FILM COATED502
50436-0255-1ropinirole1 in 1 POUCHTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0255ROPINIROLE TABLET, FILM COATED [UNIT DOSE SERVICES]2Legacy NDC, 2 package rows20180404_28bc01e9-ac47-45c9-a0c1-21e85f5a23b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314208rOPINIRole HCl 1 MG Oral TabletPSN28bc01e9-ac47-45c9-a0c1-21e85f5a23b62
314208ropinirole 1 MG Oral TabletSCD28bc01e9-ac47-45c9-a0c1-21e85f5a23b62
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY28bc01e9-ac47-45c9-a0c1-21e85f5a23b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0255-15043602550150 in 1 BOX, UNIT-DOSEHistorical