FDA.reportPublic FDA data

NDC 53270-0126-1 - VARIZIG

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53270-0126
Requested NDC
53270-0126-1
Package NDCs from labels
53270-0126-1, 53270-0126-2
Manufacturer
Cangene BioPharma | Emergent Biosolutions Canada Inc
Effective date
2018-12-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VARIZIG - Cangene BioPharma | Emergent Biosolutions Canada IncCangene BioPharma | Emergent Biosolutions Canada Inc2018-12-14PLASMA DERIVATIVE

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53270-0126-22023-11-28C16284748780-1ba0f9c33-101e-a910-e053-dadaa90a0b85These 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
53270-0126-22021-01-29C16284748780-1ba0f9c33-101e-a910-e053-dadaa90a0b85These 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53270-0126-1ML - Milliliter53270-0126533b77e9-d09a-4721-ab8c-05f80d55e25812015-07-20
53270-0126-2ML - Milliliter53270-01265c1b7ebd-3a5c-49b6-bb7f-2eef4ceb2e5412015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN VARICELLA-ZOSTER IMMUNE GLOBULINACTIVE INGREDIENT33T61IWL27VARIZIG (VARICELLA ZOSTER IMMUNE GLOBULIN (HUMAN)) LIQUID [CANGENE BIOPHARMA]4
HUMAN VARICELLA-ZOSTER IMMUNE GLOBULINACTIVE MOIETY33T61IWL27VARIZIG (VARICELLA ZOSTER IMMUNE GLOBULIN (HUMAN)) LIQUID [CANGENE BIOPHARMA]4

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Virus Nosode 4003VIRUS NOSODEProfessional Complementary Health Formulas626d937d-45db-4ccf-a75b-e961e2a808522026-01-08WarningsExact identifier
unii: 33T61IWL27
Low Virus Nosode 4023LOW VIRUS NOSODEProfessional Complementary Health Formulas670965b0-9b0b-4068-b089-701db0a5ac132026-01-08WarningsExact identifier
unii: 33T61IWL27
Childhood Immunization Detox 6032CHILDHOOD IMMUNIZATION DETOXProfessional Complementary Health Formulas4d455d07-3197-44d6-99d6-488fcdb50f952026-01-08WarningsExact identifier
unii: 33T61IWL27
Childhood Diseases Nosode Combination 9408CHILDHOOD DISEASES NOSODE COMBINATIONProfessional Complementary Health Formulasa9a7ffcf-03a7-4799-9574-fbbba8a757122026-01-08WarningsExact identifier
unii: 33T61IWL27
Shingles Nosode 4028SHINGLES NOSODEProfessional Complementary Health Formulase71d917a-af9f-41e9-a3de-cb588db7e0222026-01-08WarningsExact identifier
unii: 33T61IWL27

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.