Truvada
These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA (emtricitabine/tenofovir disoproxil fumarate) tablets Initial U.S. Approval: 2004
Approved
Approval ID
7fbc31c3-48d3-4508-8717-1cdfbf085b4d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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 Code52959-969
Application NumberNDA021752
Product Classification
M
Marketing Category
C73594
G
Generic Name
emtricitabine and tenofovir disoproxil fumarate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2011
FDA Product Classification
INGREDIENTS (13)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
emtricitabineActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
tenofovir disoproxil fumarateActive
Quantity: 300 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
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
triacetinInactive
Code: XHX3C3X673
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT