yellow)
• Noxafil Oral Suspension:
Inactive ingredients: polysorbate 80, simethicone, sodium benzoate, sodium citrate dihydrate, citric acid monohydrate, glycerin, xanthan gum, liquid glucose, titanium dioxide, artificial cherry flavor, and purified water
This Patient Information has been approved by the U.S. Food and Drug Administration.
Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Delayed-Release Tablets: Manuf. by: N. V. Organon, Kloosterstraat 6, 5349 AB Oss, Netherlands
Oral Suspension: Manuf. by: Patheon Inc., Whitby, Ontario, Canada L1N 5Z5
For patent information: www.merck.com/product/patent/home.html
The trademarks depicted in this piece are owned by their respective companies.
Copyright © 2006, 2010, 2013 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
Revised: 11/2013
usppi-mk5592-mtl-1311r012
PRINCIPAL DISPLAY PANEL - 105 mL Bottle Label
NDC 0085-1328-01
NOXAFIL®
(posaconazole)
Oral Suspension
200 mg/5 mL
Each mL contains: 40 mg posaconazole.
SHAKE WELL BEFORE EACH USE.
Rx only
105 mL
28343337
Principal Display Panel - 105 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 100 mg Bottle Label
NDC 0085-4324-02
Noxafil®
(posaconazole)
delayed-release tablets
100 mg
Each tablet contains 100 mg posaconazole.
Rx only
60 Tablets
Principal Display Panel - 100 mg Bottle Label
NOXAFIL
posaconazole suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0085-1328
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
posaconazole (posaconazole) posaconazole 40 mg in 1 mL
Inactive Ingredients
Ingredient Name
Strength
polysorbate 80
sodium benzoate
trisodium citrate dihydrate
citric acid monohydrate
glycerin
xanthan gum
anhydrous dextrose
titanium dioxide
water
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:0085-1328-01 1 in 1 CARTON
1
105 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
NDA NDA022003 09/15/2006
NOXAFIL
posaconazole tablet, coated
&nb
