TENOFOVIR DISOPROXIL FUMARATE (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

300mg
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TENOFOVIR DISOPROXIL FUMARATE tenofovir disoproxil fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-758(NDC:64380-714)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR DISOPROXIL FUMARATE 300 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
STARCH, CORN
TITANIUM DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (5 MPA.S)
LACTOSE MONOHYDRATE
Product Characteristics
Color white Score no score
Shape ROUND (convex) Size 13mm
Flavor Imprint Code TDF
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50268-758-12 20 BLISTER PACK in 1 BOX contains a BLISTER PACK (50268-758-11)
1 NDC:50268-758-11 1 TABLET in 1 BLISTER PACK This package is contained within the BOX (50268-758-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090742 03/30/2020
Labeler — AvPAK (832926666)

Revised: 01/2022 AvPAK

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