Voriconazole (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 200 MG Vial Label

NDC 70594-067-01
Rx Only

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 OnlyDiscard Unused Portion

PRINCIPAL DISPLAY PANEL -- 200 MG Vial Label
(click image for full-size original)
VORICONAZOLE voriconazole injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70594-067
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VORICONAZOLE (VORICONAZOLE) VORICONAZOLE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL BETADEX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70594-067-01 1 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE
1 20 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (70594-067-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208562 08/24/2023
Labeler — Xellia Pharmaceuticals USA LLC (116768762)

Revised: 01/2023 Xellia Pharmaceuticals USA LLC

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