FDA.reportPublic FDA data

0.63 ML lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES/ML Injection

RxCUI
2741622
RxNorm name
0.63 ML lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES/ML Injection
Display name
0.63 ML lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES/ML Injection
Full name
0.63 ML lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:39:13

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125874OTARMENIlunsotogene parvec-cwha351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

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UNII Substances#

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No records found.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a7a5e936-ab4a-4609-ac10-96efedc890350.63 ML lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES/ML InjectionSCD4These highlights do not include all the information needed to use OTARMENI safely and effectively. See full prescribing information for OTARMENI. OTARMENI™ (lunsotogene parvec-cwha) suspension, for intracochlear infusion Initial U.S. Approval: 202620260427
a7a5e936-ab4a-4609-ac10-96efedc89035lunsotogene parvec-cwha 3.0 x 10(13) vg/ML in 0.63 ML InjectionPSN4These highlights do not include all the information needed to use OTARMENI safely and effectively. See full prescribing information for OTARMENI. OTARMENI™ (lunsotogene parvec-cwha) suspension, for intracochlear infusion Initial U.S. Approval: 202620260427
a7a5e936-ab4a-4609-ac10-96efedc89035lunsotogene parvec-cwha 30000000000000 VECTOR-GENOMES per 0.63 ML InjectionSY4These highlights do not include all the information needed to use OTARMENI safely and effectively. See full prescribing information for OTARMENI. OTARMENI™ (lunsotogene parvec-cwha) suspension, for intracochlear infusion Initial U.S. Approval: 202620260427