NOXAFIL: Package Insert and Label Information (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 105 mL Bottle Carton

NDC 0085-1328-01
105 mL

NOXAFIL®
(posaconazole)

Oral Suspension

200 mg/5 mL

Each mL contains: 40 mg posaconazole.

Attention: Noxafil Oral Suspension and
Delayed-Release Tablets are NOT
interchangeable due to differences in the
dosing of each formulation.

SHAKE WELL BEFORE EACH USE.

Take with a meal, or a nutritional supplement, or an acidic carbonated beverage.

Carton contains measured dosing spoon.

Rx only

PRINCIPAL DISPLAY PANEL -- 105 mL Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 Tablet Bottle Label

NDC 0085-4324-02

Noxafil®
(posaconazole)
delayed-release tablets

100 mg

Each tablet contains 100 mg posaconazole.

Attention: Noxafil Oral Suspension and Delayed-
Release Tablets are NOT interchangeable due todifferences in the dosing of each formulation.

Rx only

60 Tablets

Principal Display Panel -- 60 Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 16.7 mL Vial Carton

NDC 0085-4331-01

Noxafil®
(posaconazole)
Injection

300 mg/16.7 mL
(18 mg/mL)

For Intravenous Use Only

Requires further dilution prior to infusion.

Rx only Single-Dose Vial

Principal Display Panel -- 16.7 mL Vial Carton
(click image for full-size original)
NOXAFIL posaconazole suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG 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 Multilevel Packaging
1 NDC:0085-1328-01 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 105 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (0085-1328-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022003 09/15/2006
NOXAFIL posaconazole tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0085-4324
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
posaconazole (posaconazole) posaconazole 100 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)
MICROCRYSTALLINE CELLULOSE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
TITANIUM DIOXIDE
TALC
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score no score
Shape OVAL (oblong) Size 17mm
Flavor Imprint Code 100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0085-4324-02 60 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205053 11/25/2013
NOXAFIL posaconazole solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0085-4331
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
posaconazole (posaconazole) posaconazole 18 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BETADEX SULFOBUTYL ETHER SODIUM
EDETATE DISODIUM
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0085-4331-01 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 16.7 mL in 1 VIAL, GLASS This package is contained within the CARTON (0085-4331-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205596 03/13/2014
Labeler — Merck Sharp & Dohme Corp. (001317601)

Revised: 03/2020 Merck Sharp & Dohme Corp.

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