Emtricitabine and Tenofovir Disoproxil Fumarate (Page 11 of 11)

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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60219-2095
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 ANHYDROUS) TENOFOVIR DISOPROXIL FUMARATE 300 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code AC24
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60219-2095-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209721 08/26/2018
Labeler — Amneal Pharmaceuticals NY LLC (123797875)

Revised: 12/2022 Amneal Pharmaceuticals NY LLC

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