Abiraterone Acetate (Page 7 of 7)

Package/Label Display Panel

Abiraterone Acetate Tablets, USP

250 mg

30 Tablets

carton label
(click image for full-size original)
ABIRATERONE ACETATE abiraterone acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-6948(NDC:60505-4327)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Abiraterone Acetate (Abiraterone) Abiraterone Acetate 250 mg
Inactive Ingredients
Ingredient Name Strength
Lactose Monohydrate
Magnesium Stearate
Sodium Lauryl Sulfate
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (Biconvex) Size 16mm
Flavor Imprint Code A250;APO
# Item Code Package Description Multilevel Packaging
1 NDC:0904-6948-04 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (0904-6948-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208453 11/23/2018
Labeler — Major Pharmaceuticals (191427277)
Registrant — Apotex Inc. (209429182)

Revised: 12/2021 Major Pharmaceuticals

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