FDA.reportPublic FDA data

1.2 ML garadacimab-gxii 167 MG/ML Auto-Injector

RxCUI
2717175
RxNorm name
1.2 ML garadacimab-gxii 167 MG/ML Auto-Injector
Display name
1.2 ML garadacimab-gxii 167 MG/ML Auto-Injector
Full name
1.2 ML garadacimab-gxii 167 MG/ML Auto-Injector
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:46

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761367Andembrygaradacimab-gxii351(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
ANDEMBRYGARADACIMABCSL07b0b671-db81-49f0-a402-0c0219db7fa22025-06-30Warnings, Adverse reactionsExact identifier
rxcui: 2717175

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
07b0b671-db81-49f0-a402-0c0219db7fa2garadacimab-gxii 200 MG in 1.2 ML Auto-Injector [PSN] · 1.2 ML garadacimab-gxii 167 MG/ML Auto-Injector [SCD] · garadacimab-gxii 200 MG per 1.2 ML Auto-Injector [SY]35These highlights do not include all the information needed to use ANDEMBRY safely and effectively. See full prescribing information for ANDEMBRY. ANDEMBRY ® (garadacimab-gxii) injection, for subcutaneous use Initial U.S. Approval: 202520250630