FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
63629-7023
11-digit product format
636297023
Labeler code
63629
Product ID
63629-7023_1037663b-92b6-41f5-84c9-5b096f1859f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7023-12020-10-16C16284748780-19d75b9cf-fe6c-f424-e053-dadaa90a57ceThese 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
63629-7023-22020-10-16C16284748780-19d75b9cf-fe6c-f424-e053-dadaa90a57ceThese 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
63629-7023-12020-01-31C16284748780-19d75b9cf-fe6c-f424-e053-dadaa90a57ceThese 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
63629-7023-22020-01-31C16284748780-19d75b9cf-fe6c-f424-e053-dadaa90a57ceThese 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