VARIZIG
These highlights do not include all the information needed to use VARIZIG safely and effectively. See full prescribing information for VARIZIG. VARIZIG [Varicella Zoster Immune Globulin (Human)] for intramuscular administration only. Sterile Solution for Injection Initial U.S. Approval: 2012
Approved
Approval ID
1cec80c5-a2b3-459f-959e-d6febfd2671c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 22, 2023
Manufacturers
FDA
Saol Therapeutics
DUNS: 080040201
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70257-126
Application NumberBLA125430
Product Classification
M
Marketing Category
C73585
G
Generic Name
HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMarch 22, 2023
FDA Product Classification
INGREDIENTS (3)
Polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MALTOSE, UNSPECIFIED FORMInactive
Code: XJ6S9RV06F
Classification: IACT
HUMAN VARICELLA-ZOSTER IMMUNE GLOBULINActive
Quantity: 125 [iU] in 1.2 mL
Code: 33T61IWL27
Classification: ACTIB