PREZISTA
These highlights do not include all the information needed to use PREZISTA safely and effectively. See Full Prescribing Information for PREZISTA. PREZISTA (darunavir) Tablet, Film Coated for Oral use Initial U.S. Approval – 2006
Approved
Approval ID
4cde01bb-230b-42d8-a9e1-4c7da1a01b76
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
darunavir ethanolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0672
Application NumberNDA021976
Product Classification
M
Marketing Category
C73594
G
Generic Name
darunavir ethanolate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2010
FDA Product Classification
INGREDIENTS (10)
DARUNAVIR ETHANOLATEActive
Quantity: 400 mg in 1 1
Code: 33O78XF0BW
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
darunavir ethanolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0773
Application NumberNDA021976
Product Classification
M
Marketing Category
C73594
G
Generic Name
darunavir ethanolate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2010
FDA Product Classification
INGREDIENTS (10)
DARUNAVIR ETHANOLATEActive
Quantity: 600 mg in 1 1
Code: 33O78XF0BW
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT