Basic Information
Paliperidone
72819-158
Regulatory Information
72819-158
ANDA203802
C73584
September 28, 2023
USA
These highlights do not include all the information needed to use PALIPERIDONE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PALIPERIDONE EXTENDED-RELEASE TABLETS. PALIPERIDONE extended-release tablets, for oral use Initial U.S. Approval: 2006
HUMAN PRESCRIPTION DRUG LABEL
2
Company Information
026836212
Active Ingredients
BUTYLATED HYDROXYTOLUENE
Code: 1P9D0Z171K
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Code: 9XZ8H6N6OH
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
SODIUM STEARYL FUMARATE
Code: 7CV7WJK4UI
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
CELLULOSE ACETATE
Code: 3J2P07GVB6
Class Code: IACT
POLYETHYLENE OXIDE 200000
Code: 11628IH70O
Class Code: IACT
POLYETHYLENE OXIDE 5000000
Code: 3IG9032SAH
Class Code: IACT
SODIUM CHLORIDE
Code: 451W47IQ8X
Class Code: IACT
POLYVINYL ALCOHOL, UNSPECIFIED
Code: 532B59J990
Class Code: IACT
Active Moieties
PALIPERIDONE
Code: 838F01T721