FDA.reportPublic FDA data

HEMGENIX Kit Patient Weight 116 - 120 KG

RxCUI
2626809
RxNorm name
HEMGENIX Kit Patient Weight 116 - 120 KG
Display name
HEMGENIX Kit Patient Weight 116 - 120 KG
Full name
HEMGENIX Kit Patient Weight 116 - 120 KG
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:53

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125772Hemgenixetranacogene dezaparvovec-drlb351(a)Rx2026-06-01

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
HEMGENIXETRANACOGENE DEZAPARVOVECCSL Behring35b2db65-4c6c-4173-ab56-b2bca69193bd2026-05-01Warnings, Adverse reactionsExact identifier
rxcui: 2626809

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
35b2db65-4c6c-4173-ab56-b2bca69193bdHEMGENIX Kit Patient Weight 116 - 120 KGPSN8These highlights do not include all the information needed to use HEMGENIX safely and effectively. See full prescribing information for HEMGENIX. HEMGENIX (etranacogene dezaparvovec-drlb) suspension, for intravenous infusion Initial U.S. Approval: 202220260501
35b2db65-4c6c-4173-ab56-b2bca69193bd{24 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection [Hemgenix]) } Pack [Hemgenix Kit 116 - 120 KG]BPCK8These highlights do not include all the information needed to use HEMGENIX safely and effectively. See full prescribing information for HEMGENIX. HEMGENIX (etranacogene dezaparvovec-drlb) suspension, for intravenous infusion Initial U.S. Approval: 202220260501
35b2db65-4c6c-4173-ab56-b2bca69193bdHemgenix Kit Patient Weight 116 - 120 KGSY8These highlights do not include all the information needed to use HEMGENIX safely and effectively. See full prescribing information for HEMGENIX. HEMGENIX (etranacogene dezaparvovec-drlb) suspension, for intravenous infusion Initial U.S. Approval: 202220260501