Ropinirole

Product NDC
63629-6452
11-digit product format
636296452
Labeler code
63629
Product ID
63629-6452_6948b7b2-c862-4cf2-b863-d7854e62ff04
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
3 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#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-6452-16362964520160 TABLET in 1 BOTTLE (63629-6452-1) 60 tablet2017-02-220000-00-00NoNoCurrent
63629-6452-26362964520230 TABLET in 1 BOTTLE (63629-6452-2) 30 tablet2016-11-170000-00-00NoNoCurrent