ropinirole

Product NDC
63629-8123
11-digit product format
636298123
Labeler code
63629
Product ID
63629-8123_259e4ea6-fd56-4cc4-a09e-4b2c75e9982e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204022
Marketing category
ANDA
Marketing start
2018-10-17
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8123-16362981230130 TABLET, FILM COATED in 1 BOTTLE (63629-8123-1) 2019-07-230000-00-00NoNoCurrent