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 useInitial U.S. Approval: 2006
Approved
Approval ID
ed977166-7ac0-4a8c-a10c-4b19a69403c0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2024
Manufacturers
FDA
EXELAN PHARMACEUTICALS INC.
DUNS: 967795266
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
darunavir 600 mg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-737
Application NumberANDA206288
Product Classification
M
Marketing Category
C73584
G
Generic Name
darunavir 600 mg
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2024
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DARUNAVIR HYDRATEActive
Quantity: 600 mg in 1 1
Code: KPC4NRB25L
Classification: ACTIM
darunavir 800 mg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-738
Application NumberANDA206288
Product Classification
M
Marketing Category
C73584
G
Generic Name
darunavir 800 mg
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2024
FDA Product Classification
INGREDIENTS (9)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DARUNAVIR HYDRATEActive
Quantity: 800 mg in 1 1
Code: KPC4NRB25L
Classification: ACTIM