Ropinirole

Product NDC
0054-0120
11-digit product format
000540120
Labeler code
0054
Product ID
0054-0120_89b0f8ed-b89f-461b-a0d7-6a52a82aa57d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rOPINIRole
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA077852
Marketing category
ANDA
Marketing start
2008-05-05
Marketing end
2021-04-09
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
3 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0120-25EA - Each0054-0120424ada85-68fd-4c37-a7eb-752f918ec9cd12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-0120-2500054012025100 TABLET in 1 BOTTLE (0054-0120-25) 100 tablet2008-05-052021-04-09NoNoCurrent