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
974d2ec8-1b51-4e69-991d-0d5dea8360f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 3, 2024
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 3
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 Code59651-167
Application NumberANDA211640
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 3, 2024
Generic NameEmtricitabine and Tenofovir Disoproxil Fumarate
INGREDIENTS (10)
EMTRICITABINEActive
Quantity: 167 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 250 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Emtricitabine and Tenofovir Disoproxil Fumarate
PRODUCT DETAILS
NDC Product Code59651-166
Application NumberANDA211640
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 3, 2024
Generic NameEmtricitabine and Tenofovir Disoproxil Fumarate
INGREDIENTS (10)
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
EMTRICITABINEActive
Quantity: 133 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 200 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
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
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Emtricitabine and Tenofovir Disoproxil Fumarate
PRODUCT DETAILS
NDC Product Code59651-165
Application NumberANDA211640
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 3, 2024
Generic NameEmtricitabine and Tenofovir Disoproxil Fumarate
INGREDIENTS (10)
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
EMTRICITABINEActive
Quantity: 100 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 150 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT