Basic Information
PREZCOBIX
59676-575
Regulatory Information
59676-575
NDA205395
C73594
August 15, 2023
USA
These highlights do not include all the information needed to use PREZCOBIX safely and effectively. See full prescribing information for PREZCOBIX. PREZCOBIX (darunavir and cobicistat) tablets, for oral use Initial U.S. Approval: 2015
HUMAN PRESCRIPTION DRUG LABEL
23
Company Information
804684207
Active Ingredients
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
CROSPOVIDONE (120 .MU.M)
Code: 68401960MK
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
POLYVINYL ALCOHOL, UNSPECIFIED
Code: 532B59J990
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
Active Moieties
COBICISTAT
Code: LW2E03M5PG
DARUNAVIR
Code: YO603Y8113