VORICONAZOLE- voriconazole injection, powder, lyophilized, for solution 
Zydus Lifesciences Limited

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VORICONAZOLE FOR INJECTION

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

figure02

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

figure03
VORICONAZOLE 
voriconazole injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1413
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VORICONAZOLE (UNII: JFU09I87TR) (VORICONAZOLE - UNII:JFU09I87TR) VORICONAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SULFOBUTYLETHER .BETA.-CYCLODEXTRIN (UNII: 2PP9364507)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1413-11 in 1 CARTON01/03/201903/25/2025
120 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20898301/03/201907/25/2025
Labeler - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(70771-1413) , MANUFACTURE(70771-1413)

Revised: 7/2025
Document Id: 824df9e8-7988-480d-9c50-8f1468f5ee99
Set id: 41c0c17b-0861-420d-bbfc-6e1143a05b40
Version: 5
Effective Time: 20250725
 
Zydus Lifesciences Limited