Ketoconazole (Page 6 of 6)

Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 26110
Dist. by: Taro Pharmaceuticals U.S.A., Inc. , Hawthorne, NY 10532

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

Revised: August, 2013

79775-0813-3

PRINCIPAL DISPLAY PANEL — 200 mg Tablet Bottle Label

NDC 33261-0739-30

30 Tablets

Ketoconazole
Tablets, USP
200 mg

DISPENSE THE ACCOMPANYING MEDICATION GUIDE TO EACH PATIENT.

Rx only

IMAGE LABEL
(click image for full-size original)
KETOCONAZOLE
ketoconazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-739(NDC:51672-4026)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONES
Product Characteristics
Color WHITE (White to off-white) Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code T;57
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-739-30 30 TABLET (30 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075319 06/15/1999
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 01/2014 Aidarex Pharmaceuticals LLC

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.

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 © 2020. All Rights Reserved.