ropinirole hydrochloride

Product NDC
50090-4810
11-digit product format
500904810
Labeler code
50090
Product ID
50090-4810_bceb077b-808c-4f18-9725-f2ee15b0835c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078110
Marketing category
ANDA
Marketing start
2011-09-20
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
50090-4810-0ropinirole hydrochloride30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4810ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20210416_38ec83ba-064b-4d35-a7e4-3d5d8362b18d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562704rOPINIRole HCl 4 MG Oral TabletPSN38ec83ba-064b-4d35-a7e4-3d5d8362b18d3
562704ropinirole 4 MG Oral TabletSCD38ec83ba-064b-4d35-a7e4-3d5d8362b18d3
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY38ec83ba-064b-4d35-a7e4-3d5d8362b18d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4810-05009048100030 TABLET, FILM COATED in 1 BOTTLE (50090-4810-0) 2019-12-260000-00-00NoNoCurrent