NDC Code(s) : 55154-0082-5
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TRUVADAemtricitabine and tenofovir disoproxil fumarate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-0082(NDC:61958-0701)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TENOFOVIR DISOPROXIL FUMARATE(UNII: OTT9J7900I)
(TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) 		TENOFOVIR DISOPROXIL FUMARATE300 mg
EMTRICITABINE(UNII: G70B4ETF4S)
(EMTRICITABINE - UNII:G70B4ETF4S) 		EMTRICITABINE200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
HYPROMELLOSE 2910 (15000 MPA.S)(UNII: 288VBX44JC)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color BLUE Score no score
Shape OVAL (capsule) Size 19 mm
Flavor Imprint Code GILEAD;701
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-0082-51 in 1 CARTON
13 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021752 08/02/2004

PRINCIPAL DISPLAY PANEL

Truvada®
3 Tablets

(emtricitabine and tenofovir disoproxil fumarate) tablets

200 mg/ 300 mg

Bottle label

PRINCIPAL DISPLAY PANEL

NDC 55154-0082-5

AccessPak® for HIV PEP

Basic Regimen

Carton Label