Basic Information
ROPINIROLE HYDROCHLORIDE
71335-0727
Regulatory Information
71335-0727
ANDA090429
C73584
August 10, 2021
USA
These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
HUMAN PRESCRIPTION DRUG LABEL
6
Company Information
171714327
Active Ingredients
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
ALUMINUM OXIDE
Code: LMI26O6933
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
Active Moieties
ROPINIROLE
Code: 030PYR8953