ABIRATERONE ACETATE (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

500
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ABIRATERONE ACETATE abiraterone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-073(NDC:69238-1754)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ABIRATERONE ACETATE (ABIRATERONE) ABIRATERONE ACETATE 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYVINYL ALCOHOL, UNSPECIFIED
TALC
TITANIUM DIOXIDE
SILICON DIOXIDE
MICROCRYSTALLINE CELLULOSE
Product Characteristics
Color purple Score no score
Shape OVAL Size 20mm
Flavor Imprint Code 1754
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-073-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208327 04/29/2021
Labeler — AvKARE (796560394)

Revised: 10/2022 AvKARE

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