Abiraterone Acetate: Package Insert and Label Information (Page 8 of 8)

PRINCIPAL DISPLAY PANEL – 500 mg

NDC 0378-6921-91

Abiraterone
Acetate
Tablets, USP
500 mg

Rx only 60 Film-Coated Tablets

Each film-coated tablet contains:
Abiraterone acetate, USP 500 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 crushor 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

RM6921D1

Abiraterone Acetate Tablets, USP 500 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 250 mg

NDC 0378-6920-78

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

Abiraterone Acetate Tablets, USP 250 mg Bottle Label
(click image for full-size original)
ABIRATERONE ACETATE abiraterone acetate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-6921
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ABIRATERONE ACETATE (ABIRATERONE) ABIRATERONE ACETATE 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (50 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 101
MICROCRYSTALLINE CELLULOSE 102
POLYDEXTROSE
POLYETHYLENE GLYCOL 8000
POVIDONE K30
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 16mm
Flavor Imprint Code M;AB500
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0378-6921-91 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208446 12/14/2020
ABIRATERONE ACETATE abiraterone acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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:0378-6920-78 120 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208446 11/21/2018
Labeler — Mylan Pharmaceuticals Inc. (059295980)

Revised: 03/2022 Mylan Pharmaceuticals Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.