Truvada (Page 9 of 9)

PRINCIPAL DISPLAY PANEL — Representative Bottle Label

NDC 61958-0701-1

Truvada ®
(emtricitabine and tenofovir
disoproxil fumarate)
Tablets

30 tablets

Rx only

Repacked by:
H.J. Harkins Company, Inc.
Nipomo, CA 93444

PRINCIPAL DISPLAY PANEL -- Representative Bottle Label
(click image for full-size original)
TRUVADA emtricitabine and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-969(NDC:61958-0701)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
emtricitabine (emtricitabine) emtricitabine 200 mg
tenofovir disoproxil fumarate (tenofovir) tenofovir disoproxil fumarate 300 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
lactose monohydrate
magnesium stearate
cellulose, microcrystalline
starch, corn
water
FD&C Blue No. 2
aluminum oxide
hypromelloses
titanium dioxide
triacetin
Product Characteristics
Color BLUE Score no score
Shape OVAL (Capsule-shaped) Size 19mm
Flavor Imprint Code GILEAD;701
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-969-03 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021752 08/02/2004
Labeler — H.J. Harkins Company, Inc. (147681894)
Establishment
Name Address ID/FEI Operations
Gilead Sciences, Inc. 185049848 manufacture

Revised: 12/2011 H.J. Harkins Company, Inc.

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