FDA.reportPublic FDA data

10 ML Xembify 200 MG/ML Injection

RxCUI
2196391
RxNorm name
10 ML Xembify 200 MG/ML Injection
Display name
10 ML Xembify 200 MG/ML Injection
Full name
10 ML Xembify 200 MG/ML Injection
Term type
SY
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#

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.

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-a3b2-7bf7e1adaaceXembify 20 % (2 GM in 10 ML) Injection [PSN] · 10 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify] [SBD] · 10 ML Xembify 200 MG/ML Injection [SY] · Xembify 20 % (2 GM per 10 ML) Injection [SY]412These 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