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
92b286d5-1ee5-435b-9e1d-2e95c7f2ec69
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
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 Code60219-1144
Application NumberANDA212493
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darunavir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (12)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
DARUNAVIRActive
Quantity: 600 mg in 1 1
Code: YO603Y8113
Classification: ACTIB
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Darunavir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60219-1145
Application NumberANDA212493
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darunavir
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2023
FDA Product Classification
INGREDIENTS (12)
DARUNAVIRActive
Quantity: 800 mg in 1 1
Code: YO603Y8113
Classification: ACTIB
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT