VARIZIG

Basic Information

Product Name

VARIZIG

FDA Product Code

70257-126

Regulatory Information

NDC Product Code

70257-126

Application Number

BLA125430

Marketing Category

C73585

Effective Date

March 22, 2023

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

Polysorbate 80

Code: 6OZP39ZG8H

Class Code: IACT

MALTOSE, UNSPECIFIED FORM

Code: XJ6S9RV06F

Class Code: IACT

HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN

Quantity: 125 [iU] in 1.2 mL

Code: 33T61IWL27

Class Code: ACTIB

Active Moieties

HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN

Code: 33T61IWL27

Basic Information

Regulatory Information

Company Information

Active Ingredients

Polysorbate 80

MALTOSE, UNSPECIFIED FORM

Active Moieties

HUMAN VARICELLA-ZOSTER IMMUNE GLOBULIN