Ropinirole

Product NDC
63629-7137
11-digit product format
636297137
Labeler code
63629
Product ID
63629-7137_196ee634-84d6-4331-985d-009ea35d23c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rOPINIRole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077852
Marketing category
ANDA
Marketing start
2008-05-05
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7137-12020-10-16C16284748780-19d75b9d0-562f-f424-e053-dadaa90a57cefc1f418c-f229-4bf0-88a6-1b2c84a18041
63629-7137-12020-01-31C16284748780-19d75b9d0-562f-f424-e053-dadaa90a57cefc1f418c-f229-4bf0-88a6-1b2c84a18041

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7137-16362971370130 TABLET in 1 BOTTLE (63629-7137-1) 30 tablet2016-11-170000-00-00NoNoCurrent