FDA.reportPublic FDA data

50 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]

RxCUI
2196493
RxNorm name
50 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]
Display name
50 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]
Full name
50 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]
Term type
SBD
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)Rx2026-06-01

RxNav Current And Historical NDCs#

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UNII Substances#

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DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
8c174b11-a061-412e-a3b2-7bf7e1adaace50 ML immune globulin subcutaneous (human) - klhw 200 MG/ML Injection [Xembify]SBD12These 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
8c174b11-a061-412e-a3b2-7bf7e1adaaceXembify 20 % (10 GM per 50 ML) InjectionSY12These 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
8c174b11-a061-412e-a3b2-7bf7e1adaaceXembify 20 % (10 GM in 50 ML) InjectionPSN12These 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
8c174b11-a061-412e-a3b2-7bf7e1adaace50 ML Xembify 200 MG/ML InjectionSY12These 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