FDA.reportPublic FDA data

immune globulin subcutaneous (human) - klhw 20 % (4 GM in 20 ML) Injection

RxCUI
2196490
RxNorm name
immune globulin subcutaneous (human) - klhw 20 % (4 GM in 20 ML) Injection
Display name
immune globulin subcutaneous (human) - klhw 20 % (4 GM in 20 ML) Injection
Full name
immune globulin subcutaneous (human) - klhw 20 % (4 GM in 20 ML) Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125683Xembifyimmune globulin subcutaneous, human-klhw351(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
8c174b11-a061-412e-a3b2-7bf7e1adaaceimmune globulin subcutaneous (human) - klhw 20 % (4 GM in 20 ML) Injection [PSN] · 20 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [SCD]212These highlights do not include all the information needed to use XEMBIFY safely and effectively. See full prescribing information for XEMBIFY. XEMBIFY (immune globulin subcutaneous, human – klhw) 20% solution Initial U.S. Approval: 201920250317