ropinirole hydrochloride

Product NDC: 63629-7152
11-digit product format: 636297152
Labeler code: 63629
Product ID: 63629-7152_c9befec7-7507-4a4c-a67f-4d5b9103c90b
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: 1 mg/1
Pharmacologic classes: Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-7152-1	2020-10-16	C162847	48780-1	9d75b9cf-fe6c-f424-e053-dadaa90a57ce	These 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
63629-7152-1	2020-01-31	C162847	48780-1	9d75b9cf-fe6c-f424-e053-dadaa90a57ce	These 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D7ZD41RZI9	ROPINIROLE HYDROCHLORIDE	91374-20-8	ROPINIROLE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-7152-1	63629715201	30 TABLET, FILM COATED in 1 BOTTLE (63629-7152-1)	2016-12-08	0000-00-00	No	No	Current