Abiraterone (Page 12 of 12)

PRINCIPAL DISPLAY PANEL

Abiraterone Acetate
Tablets, 250 mg

Rx Only

72789213 Label
(click image for full-size original)
ABIRATERONE abiraterone acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72789-213(NDC:0143-9597)
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
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
SODIUM LAURYL SULFATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white Score no score
Shape OVAL Size 16mm
Flavor Imprint Code WW597
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72789-213-98 120 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208339 11/23/2018
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (72789-213)

Revised: 04/2022 PD-Rx Pharmaceuticals, Inc.

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