![VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/41c0c17b-0861-420d-bbfc-6e1143a05b40/36fbc480-a0ef-419c-8dcf-d5ed15ae53b6-02.jpg)
![VORICONAZOLE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CADILA HEALTHCARE LIMITED]](https://medic.hrt.org//dailymed/images/41c0c17b-0861-420d-bbfc-6e1143a05b40/36fbc480-a0ef-419c-8dcf-d5ed15ae53b6-03.jpg)
| NDC | 70771-1413-1 |
| Set ID | 41c0c17b-0861-420d-bbfc-6e1143a05b40 |
| Category | HUMAN PRESCRIPTION DRUG LABEL |
| Packager | Cadila Healthcare Limited |
| Generic Name | |
| Product Class | Azole Antifungal |
| Product Number | |
| Application Number | ANDA208983 |
- SPL UNCLASSIFIED SECTION
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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 - Cadila Healthcare Limited (918596198) Establishment Name Address ID/FEI Business Operations Cadila Healthcare Limited 918596198 ANALYSIS(70771-1413) , MANUFACTURE(70771-1413)