Abiraterone Acetate (Page 11 of 11)

PRINCIPAL DISPLAY PANEL – 250 mg

NDC 51407-181-12

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).

Rx only 120 Tablets

Each tablet contains:
Abiraterone acetate, USP 250 mg

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Keep this and all medication
out of the reach of children.

Swallow whole tablet. Do not
crush or chew.

Store at 20° to 25°C (68° to 77°F);
excursions permitted in the range
from 15° to 30°C (59° to 86°F) [see
USP Controlled Room Temperature].

Usual Dosage: See accompanying
prescribing information.

Manufactured for:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in Puerto Rico

Mylan.com

RM6920DA2

Marketed/Packaged by:

GSMS, Inc.

Camarillo, CA USA 93012

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ABIRATERONE ACETATE abiraterone acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-181(NDC:0378-6920)
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
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
POVIDONE K30
SODIUM LAURYL SULFATE
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code M;AB250
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-181-12 120 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208446 10/31/2018
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-181), repack (51407-181)

Revised: 06/2022 Golden State Medical Supply, Inc.

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