PREZCOBIX
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
Approved
Approval ID
9c38fdb6-d0ba-4f16-a0e3-85d9ec334d9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2023
Manufacturers
FDA
Janssen Products LP
DUNS: 804684207
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DARUNAVIR ETHANOLATE and COBICISTAT
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59676-575
Application NumberNDA205395
Product Classification
M
Marketing Category
C73594
G
Generic Name
DARUNAVIR ETHANOLATE and COBICISTAT
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2023
FDA Product Classification
INGREDIENTS (13)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (120 .MU.M)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
DARUNAVIR ETHANOLATEActive
Quantity: 800 mg in 1 1
Code: 33O78XF0BW
Classification: ACTIM
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
COBICISTATActive
Quantity: 150 mg in 1 1
Code: LW2E03M5PG
Classification: ACTIB