ropinirole hydrochloride

Product NDC
50268-741
11-digit product format
502680741
Labeler code
50268
Product ID
50268-741_2b4c1c97-dc70-3801-e063-6394a90a7faf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA078110
Marketing category
ANDA
Marketing start
2022-08-19
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.25 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
D7ZD41RZI9ROPINIROLE HYDROCHLORIDE91374-20-8ROPINIROLE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50268-741-155026807411550 BLISTER PACK in 1 BOX (50268-741-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-741-11) 50 blister pack2022-08-19NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ropinirole hydrochlorideAvPAK2025-01-09HUMAN PRESCRIPTION DRUG LABEL2