FDA.reportPublic FDA data

Hizentra 1 GM per 5 ML Prefilled Syringe

RxCUI
2268105
RxNorm name
Hizentra 1 GM per 5 ML Prefilled Syringe
Display name
Hizentra 1 GM per 5 ML Prefilled Syringe
Full name
Hizentra 1 GM per 5 ML Prefilled Syringe
Term type
SY
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)Rx2026-08-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 5 ML Prefilled Syringe [PSN] · 5 ML immunoglobulin G, human 200 MG/ML Prefilled Syringe [Hizentra] [SBD] · 5 ML Hizentra 200 MG/ML Prefilled Syringe [SY] · Hizentra 1 GM per 5 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