FDA.reportPublic FDA data

20 ML immunoglobulin G, human 200 MG/ML Prefilled Syringe [Hizentra]

RxCUI
2287159
RxNorm name
20 ML immunoglobulin G, human 200 MG/ML Prefilled Syringe [Hizentra]
Display name
20 ML immunoglobulin G, human 200 MG/ML Prefilled Syringe [Hizentra]
Full name
20 ML immunoglobulin G, human 200 MG/ML Prefilled Syringe [Hizentra]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:05

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125350HizentraImmune Globulin Subcutaneous (Human), 20% Liquid351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

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No records found.

UNII Substances#

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No records found.

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
7b58f5ff-0316-49a3-b585-1f6003ddb953Hizentra 20 % in 20 ML Prefilled Syringe [PSN] · 20 ML immunoglobulin G, human 200 MG/ML Prefilled Syringe [Hizentra] [SBD] · 20 ML Hizentra 200 MG/ML Prefilled Syringe [SY] · Hizentra 4 GM per 20 ML Prefilled Syringe [SY]426These highlights do not include all the information needed to use HIZENTRA ® safely and effectively. See full prescribing information for HIZENTRA. HIZENTRA, Immune Globulin Subcutaneous (Human), 20% Liquid Initial U.S. Approval: 201020230420