FDA.reportPublic FDA data

etranacogene dezaparvovec-drlb Kit Patient Weight 111 - 115 KG

RxCUI
2626806
RxNorm name
etranacogene dezaparvovec-drlb Kit Patient Weight 111 - 115 KG
Display name
etranacogene dezaparvovec-drlb Kit Patient Weight 111 - 115 KG
Full name
etranacogene dezaparvovec-drlb Kit Patient Weight 111 - 115 KG
Term type
SY
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: 2626806

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
35b2db65-4c6c-4173-ab56-b2bca69193bdetranacogene dezaparvovec-drlb Kit Patient Weight 111 - 115 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
35b2db65-4c6c-4173-ab56-b2bca69193bd{23 (10 ML etranacogene dezaparvovec-drlb 10000000000000 VECTOR-GENOMES/ML Injection) } PackGPCK8These 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-b2bca69193bdetranacogene dezaparvovec-drlb Kit Patient Weight 111 - 115 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