Label: VORICONAZOLE injection, powder, lyophilized, for solution
- NDC Code(s): 70771-1413-1
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 5, 2022
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Container Label
NDC 70771-1413-1
Voriconazole
for Injection
200 mg per vial
Sterile Single-Dose Vial
For Intravenous Infusion Only
Rx Only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Carton Label
NDC 70771-1413-1
Voriconazole
for Injection
200 mg per vial
Sterile Single-Dose Vial
For Intravenous Infusion Only
1 Vial
Rx Only
-
INGREDIENTS AND APPEARANCE
VORICONAZOLE
voriconazole injection, powder, lyophilized, for solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1413 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VORICONAZOLE (UNII: JFU09I87TR) (VORICONAZOLE - UNII:JFU09I87TR) VORICONAZOLE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength SULFOBUTYLETHER .BETA.-CYCLODEXTRIN (UNII: 2PP9364507) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1413-1 1 in 1 CARTON 01/03/2019 1 20 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208983 01/03/2019 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(70771-1413) , MANUFACTURE(70771-1413)