Emtriva
These highlights do not include all the information needed to use EMTRIVA safely and effectively. See full prescribing information for EMTRIVA.EMTRIVA (emtricitabine) capsule for oral useEMTRIVA (emtricitabine) solution for oral useInitial U.S. Approval: 2003
Approved
Approval ID
39ae3070-9b9b-41f3-b058-2e240b4ac18e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
emtricitabine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4853
Application NumberNDA021500
Product Classification
M
Marketing Category
C73594
G
Generic Name
emtricitabine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2012
FDA Product Classification
INGREDIENTS (9)
emtricitabineActive
Quantity: 200 mg in 1 1
Code: G70B4ETF4S
Classification: ACTIB
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
crospovidoneInactive
Code: 68401960MK
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT