FDA.reportPublic FDA data

CUVITRU 20 % in 40 mL Injection

RxCUI
1813424
RxNorm name
CUVITRU 20 % in 40 mL Injection
Display name
CUVITRU 20 % in 40 mL Injection
Full name
CUVITRU 20 % in 40 mL Injection
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:10

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125596CuvitruImmune Globulin Subcutaneous (Human), 20% Solution351(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
9aad7ec9-6097-4805-8f1b-898bec35f218CUVITRU 20 % in 40 mL Injection [PSN] · 40 ML immunoglobulin G, human 200 MG/ML Injection [Cuvitru] [SBD] · CUVITRU 20 % per 40 ML Injection [SY] · CUVITRU 8 GM per 40 ML Injection [SY]419These highlights do not include all the information needed to use CUVITRU ® safely and effectively. See full prescribing information for CUVITRU. CUVITRU ® , Immune Globulin Subcutaneous (Human), 20% Solution Initial U.S. Approval: 201620251125