Abiraterone Acetate (Page 7 of 7)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION

Container pack: 120’s

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

container
(click image for full-size original)
ABIRATERONE ACETATE abiraterone acetate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-358
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
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
Polyethylene Glycol, Unspecified
POVIDONE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL Size 16mm
Flavor Imprint Code 35
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43598-358-04 120 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208416 05/19/2020
Labeler — Dr. Reddys Laboratories Inc (802315887)
Establishment
Name Address ID/FEI Operations
Dr.Reddy’s Laboratories Limited FTO-7 650446243 analysis (43598-358), manufacture (43598-358)
Establishment
Name Address ID/FEI Operations
Dr. Reddy’s Laboratories Limited — FTO III 918608162 analysis (43598-358), manufacture (43598-358)

Revised: 09/2021 Dr. Reddys Laboratories Inc

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

https://medlibrary.org/lib/rx/meds/abiraterone-acetate-16/page/7/

Clinical Trials

MedLibrary.org

Medication Sections

RSS Feeds

About

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2023. All Rights Reserved.