ropinirole

Product NDC
50090-5167
11-digit product format
500905167
Labeler code
50090
Product ID
50090-5167_cd2d9796-a8b9-45c4-88f3-5e93d5bb8600
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
1 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
50090-5167-0ropinirole30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5167ROPINIROLE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20211113_443e20d7-b459-4d42-8437-098f32bd27ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314208rOPINIRole HCl 1 MG Oral TabletPSN443e20d7-b459-4d42-8437-098f32bd27ea3
314208ropinirole 1 MG Oral TabletSCD443e20d7-b459-4d42-8437-098f32bd27ea3
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY443e20d7-b459-4d42-8437-098f32bd27ea3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5167-05009051670030 TABLET, FILM COATED in 1 BOTTLE (50090-5167-0) 2020-09-240000-00-00NoNoCurrent