Darunavir
These highlights do not include all the information needed to use DARUNAVIR TABLETS safely and effectively. See Full Prescribing Information for DARUNAVIR TABLETS. DARUNAVIR tablets, for oral use Initial U.S. Approval: 2006
Approved
Approval ID
ea6e0136-75b2-4793-9500-04e6658a0a73
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Darunavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-185
Application NumberANDA215389
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darunavir
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (13)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DARUNAVIRActive
Quantity: 800 mg in 1 1
Code: YO603Y8113
Classification: ACTIB
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Darunavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-184
Application NumberANDA215389
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darunavir
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (14)
DARUNAVIRActive
Quantity: 600 mg in 1 1
Code: YO603Y8113
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT