FDA.reportPublic FDA data

ropinirole

Product NDC
50090-2068
11-digit product format
500902068
Labeler code
50090
Product ID
50090-2068_d973263f-34c3-4bcd-b854-f7547b4d4120
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090135
Marketing category
ANDA
Marketing start
2010-02-25
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2068-02023-02-07C16284748780-1f386c64a-4803-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
50090-2068-02023-01-30C16284748780-1f386c64a-4803-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2068-0ropinirole30 in 1 BOTTLETABLET, FILM COATED3024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2068-0EA - Each50090-20684f88af32-f671-4164-a777-967d457440b212019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2068ROPINIROLE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]22Legacy NDC, 1 package rows20240724_35d0074e-212b-4a1f-9cd7-974ca08d2c95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN35d0074e-212b-4a1f-9cd7-974ca08d2c9524
562704rOPINIRole HCl 4 MG Oral TabletPSN35d0074e-212b-4a1f-9cd7-974ca08d2c9524
312845ropinirole 0.25 MG Oral TabletSCD35d0074e-212b-4a1f-9cd7-974ca08d2c9524
562704ropinirole 4 MG Oral TabletSCD35d0074e-212b-4a1f-9cd7-974ca08d2c9524
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY35d0074e-212b-4a1f-9cd7-974ca08d2c9524
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY35d0074e-212b-4a1f-9cd7-974ca08d2c9524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2068-05009020680030 TABLET, FILM COATED in 1 BOTTLE (50090-2068-0) 2015-10-070000-00-00NoNoCurrent