NDC Code(s) : 39822-1077-1
Packager : XGen Pharmaceuticals DJB, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

VoriconazoleVoriconazole INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:39822-1077
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VORICONAZOLE(UNII: JFU09I87TR)
(VORICONAZOLE - UNII:JFU09I87TR) 		VORICONAZOLE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYLBETADEX (0.58-0.68 MS)(UNII: 1I96OHX6EK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:39822-1077-11 in 1 CARTON 04/09/2017
120 mL in 1 VIAL, SINGLE-USE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208562 03/09/2017

LABELER - XGen Pharmaceuticals DJB, Inc.(117380305)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 200 mg Vial Label

NDC 39822-1077-1

VORICONAZOLE FOR INJECTION

200 MG* per vial

Not made with natural rubber latex

No Preservatives

Sterile Single Dose Vial

Must be reconstituted then diluted

For Intravenous Infusion Only

Discard Unused Portion

Rx only

VORI-VL-03

PRINCIPAL DISPLAY PANEL - 200 mg Vial Carton

NDC 39822-1077-1

VORICONAZOLE FOR INJECTION

200 MG* per vial

Sterile Single Dose Vial

Must be reconstituted then diluted

For Intravenous Infusion Only

Discard Unused Portion

Not made with natural rubber latex

No Preservatives

Rx Only

1 Vial

VORI-VL-03