FDA.reportPublic FDA data

ROPINIROLE HYDROCHLORIDE

Product NDC
71335-0727
11-digit product format
713350727
Labeler code
71335
Product ID
71335-0727_fe9f5e44-c20a-4775-b3db-4485df15d6b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090429
Marketing category
ANDA
Marketing start
2016-01-29
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.5 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ROPINIROLE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312846

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
71335-0727-12024-08-20C16284748780-11030e365-4252-111a-e063-dadaa90a10e2These 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
71335-0727-22024-08-20C16284748780-11030e365-4252-111a-e063-dadaa90a10e2These 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
71335-0727-32024-08-20C16284748780-11030e365-4252-111a-e063-dadaa90a10e2These 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
71335-0727-42024-08-20C16284748780-11030e365-4252-111a-e063-dadaa90a10e2These 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
71335-0727-52024-08-20C16284748780-11030e365-4252-111a-e063-dadaa90a10e2These 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
71335-0727-12024-01-30C16284748780-11030e365-4252-111a-e063-dadaa90a10e2These 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
71335-0727-22024-01-30C16284748780-11030e365-4252-111a-e063-dadaa90a10e2These 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
71335-0727-32024-01-30C16284748780-11030e365-4252-111a-e063-dadaa90a10e2These 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
71335-0727-42024-01-30C16284748780-11030e365-4252-111a-e063-dadaa90a10e2These 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
71335-0727-52024-01-30C16284748780-11030e365-4252-111a-e063-dadaa90a10e2These 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
71335-0727-1ROPINIROLE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
71335-0727-2ROPINIROLE HYDROCHLORIDE60 in 1 BOTTLETABLET, FILM COATED608
71335-0727-3ROPINIROLE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED908
71335-0727-4ROPINIROLE HYDROCHLORIDE28 in 1 BOTTLETABLET, FILM COATED288
71335-0727-5ROPINIROLE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0727ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 5 package rows20241025_00c0ab77-914a-4e8a-bcb7-24cecacfebb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312846rOPINIRole HCl 0.5 MG Oral TabletPSN00c0ab77-914a-4e8a-bcb7-24cecacfebb18
312846ropinirole 0.5 MG Oral TabletSCD00c0ab77-914a-4e8a-bcb7-24cecacfebb18
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY00c0ab77-914a-4e8a-bcb7-24cecacfebb18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0727-17133507270130 TABLET, FILM COATED in 1 BOTTLE (71335-0727-1) 2019-02-150000-00-00NoNoCurrent
71335-0727-27133507270260 TABLET, FILM COATED in 1 BOTTLE (71335-0727-2) 2018-03-090000-00-00NoNoCurrent
71335-0727-37133507270390 TABLET, FILM COATED in 1 BOTTLE (71335-0727-3) 2018-08-140000-00-00NoNoCurrent
71335-0727-47133507270428 TABLET, FILM COATED in 1 BOTTLE (71335-0727-4) 2024-10-070000-00-00NoNoCurrent
71335-0727-571335072705100 TABLET, FILM COATED in 1 BOTTLE (71335-0727-5) 2024-10-070000-00-00NoNoCurrent