Abiraterone Acetate (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rising NDC 64980-418-12

Abiraterone
Acetate
Tablets, USP
250 mg
Warning: Women who are or may be pregnant should not handle Abiraterone Acetate Tablets without gloves (see package insert).
120 Tablets Rx only

CONTAINER LABEL
(click image for full-size original)
ABIRATERONE ACETATE abiraterone acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64980-418
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
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
POVIDONE
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color WHITE (White to off-white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code NA250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64980-418-12 120 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208371 02/25/2019
Labeler — Rising Pharmaceuticals, Inc. (041241766)
Establishment
Name Address ID/FEI Operations
Natco Pharma Limited 918588174 MANUFACTURE (64980-418)

Revised: 03/2019 Rising Pharmaceuticals, Inc.

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