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
a78b51c9-c944-4b00-af81-9ecbfbb29fd1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 22, 2022
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7172
Application NumberANDA212114
Product Classification
M
Marketing Category
C73584
G
Generic Name
Emtricitabine and Tenofovir Disoproxil Fumarate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2021
FDA Product Classification
INGREDIENTS (10)
EMTRICITABINEActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
TENOFOVIR DISOPROXIL FUMARATEActive
Quantity: 300 mg in 1 1
Code: OTT9J7900I
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT