Emtricitabine and Tenofovir Disoproxil Fumarate
These highlights do not include all the information needed to use EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS safely and effectively. See full prescribing information for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS. EMTRICITABINE and TENOFOVIR DISOPROXIL FUMARATE tablets, for oral use Initial U.S. Approval: 2004
Approved
Approval ID
9b772028-941f-4623-8948-f8867c39b80e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Emtricitabine and Tenofovir Disoproxil Fumarate
PRODUCT DETAILS
NDC Product Code53002-1653
Application NumberANDA090513
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 5, 2023
Generic NameEmtricitabine and Tenofovir Disoproxil Fumarate
INGREDIENTS (10)
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 200Inactive
Code: 5XDI2TS1EZ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT