ROPINIROLE HYDROCHLORIDE

Product NDC
61919-564
11-digit product format
619190564
Labeler code
61919
Product ID
61919-564_cc0df9b3-16e9-d642-e053-2a95a90a7726
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA090429
Marketing category
ANDA
Marketing start
2021-09-15
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-564-30EA - Each61919-564ada730f6-d922-46dd-93b2-cbf16126912012021-10-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-564-306191905643030 TABLET, FILM COATED in 1 BOTTLE (61919-564-30) 2021-09-150000-00-00NoNoCurrent