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
SILICON DIOXIDE
CROSPOVIDONE (15 MPA.S AT 5%)
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
Contains
Packaging
# 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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