ROPINIROLE HYDROCHLORIDE

Product NDC
71335-0728
11-digit product format
713350728
Labeler code
71335
Product ID
71335-0728_b57edf12-1dcd-41b8-a146-18b5d68c1a91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090429
Marketing category
ANDA
Marketing start
2016-01-29
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
0 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0728-17133507280130 TABLET, FILM COATED in 1 BOTTLE (71335-0728-1) 2018-03-130000-00-00NoNoCurrent
71335-0728-27133507280260 TABLET, FILM COATED in 1 BOTTLE (71335-0728-2) 2018-03-130000-00-00NoNoCurrent
71335-0728-37133507280328 TABLET, FILM COATED in 1 BOTTLE (71335-0728-3) 2018-03-130000-00-00NoNoCurrent