Xarelto (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

Rivaroxaban 15 mg tablet label
(click image for full-size original)

XARELTO rivaroxaban tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0578(NDC:50458-578)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
rivaroxaban (rivaroxaban) rivaroxaban 15 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline
croscarmellose sodium
hypromelloses
lactose monohydrate
magnesium stearate
sodium lauryl sulfate
polyethylene glycol 3350
titanium dioxide
ferric oxide red
Product Characteristics
Color RED Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 15;Xa
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69189-0578-1 1 TABLET, FILM COATED in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202439 03/16/2015
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-0578), repack (69189-0578)

Revised: 12/2015 Avera McKennan Hospital

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