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
f5c9cb01-6530-4db0-a326-22a499d1efdf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 25, 2023
Manufacturers
FDA
Dr.Reddys Laboratories Inc
DUNS: 802315887
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 Code43598-704
Application NumberANDA211578
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darunavir
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2023
FDA Product Classification
INGREDIENTS (9)
DarunavirActive
Quantity: 600 mg in 1 1
Code: YO603Y8113
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
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 Code43598-705
Application NumberANDA211578
Product Classification
M
Marketing Category
C73584
G
Generic Name
Darunavir
Product Specifications
Route of AdministrationORAL
Effective DateNovember 25, 2023
FDA Product Classification
INGREDIENTS (13)
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
DarunavirActive
Quantity: 800 mg in 1 1
Code: YO603Y8113
Classification: ACTIB
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Polyvinyl Alcohol, UnspecifiedInactive
Code: 532B59J990
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Fd&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Fd&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Fd&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT