FDA.reportPublic FDA data

immune globulin intravenous (human) - kthm 10 % per 50 ML Injection

RxCUI
2726016
RxNorm name
immune globulin intravenous (human) - kthm 10 % per 50 ML Injection
Display name
immune globulin intravenous (human) - kthm 10 % per 50 ML Injection
Full name
immune globulin intravenous (human) - kthm 10 % per 50 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:03

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125822QIVIGYImmune Globulin Intravenous, Human-kthm, 10% Solution351(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.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QIVIGY kthmHUMAN IMMUNOGLOBULIN GKedrion S.p.A.6f1933e0-240f-48f4-b246-8a30e63a41602026-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2726016

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
6f1933e0-240f-48f4-b246-8a30e63a4160immune globulin intravenous (human) - kthm 10 % in 50 ML Injection [PSN] · 50 ML immune globulin intravenous (human) - kthm 100 MG/ML Injection [SCD] · immune globulin intravenous (human) - kthm 10 % per 50 ML Injection [SY]34These highlights do not include all the information needed to use QIVIGY safely and effectively. See full prescribing information for QIVIGY. QIVIGY (immune globulin intravenous, human-kthm) 10% solution Initial U.S. Approval: 202520251201