FDA.reportPublic FDA data

immune globulin intravenous (human) - slra 10 % in 50 ML Injection

RxCUI
2123037
RxNorm name
immune globulin intravenous (human) - slra 10 % in 50 ML Injection
Display name
immune globulin intravenous (human) - slra 10 % in 50 ML Injection
Full name
immune globulin intravenous (human) - slra 10 % in 50 ML Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125590AscenivImmune Globulin Intravenous, Human-slra351(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
ASCENIVHUMAN IMMUNOGLOBULIN GADMA Biologics, Inc.d74f4360-3b51-496c-96fb-84c3976958d22026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2123037

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
d74f4360-3b51-496c-96fb-84c3976958d2immune globulin intravenous (human) - slra 10 % in 50 ML Injection [PSN] · 50 ML immune globulin intravenous (human) - slra 100 MG/ML Injection [SCD] · immune globulin intravenous (human) - slra 10 % per 50 ML Injection [SY]312These highlights do not include all the information needed to use ASCENIV ™ safely and effectively. See full prescribing information for ASCENIV. ASCENIV (immune globulin intravenous, human – slra) 10% Liquid Initial U.S. Approval: 201920260430