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
f8d47e60-a1af-40f4-961d-ca671078ab76
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 4, 2023
Manufacturers
FDA
Teva Pharmaceuticals, Inc.
DUNS: 022629579
Products 1
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 Code0480-7736
Application NumberANDA202118
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darunavir
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2023
FDA Product Classification
INGREDIENTS (11)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONE (35 .MU.M)Inactive
Code: 40UAA97IT9
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
DARUNAVIR HYDRATEActive
Quantity: 600 mg in 1 1
Code: KPC4NRB25L
Classification: ACTIM