Xofluza (Page 6 of 6)

BALOXAVIR MARBOXIL

Label ImageLabel Image
XOFLUZA baloxavir marboxil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4102(NDC:50242-828)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BALOXAVIR MARBOXIL (BALOXAVIR) BALOXAVIR MARBOXIL 20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
POVIDONE K25
MICROCRYSTALLINE CELLULOSE
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
HYPROMELLOSE, UNSPECIFIED
TALC
Product Characteristics
Color YELLOW (white to light yellow) Score no score
Shape OVAL Size 9mm
Flavor Imprint Code 772;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4102-0 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 2 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50090-4102-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210854 10/24/2018
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4102)

Revised: 04/2021 A-S Medication Solutions

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