FDA.reportPublic FDA data

1 ML zopapogene imadenovec-drba 500000000000 UNT/ML Injection

RxCUI
2723367
RxNorm name
1 ML zopapogene imadenovec-drba 500000000000 UNT/ML Injection
Display name
1 ML zopapogene imadenovec-drba 500000000000 UNT/ML Injection
Full name
1 ML zopapogene imadenovec-drba 500000000000 UNT/ML Injection
Term type
SCD
Status
DailyMed mapping
Updated
2026-06-04 23:38:47

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125832PAPZIMEOSzopapogene imadenovec-drba351(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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAPZIMEOSZOPAPOGENE IMADENOVECPrecigen, Inc.103db7f1-8540-4bea-935e-217d69e7aa012025-08-12Warnings, Adverse reactionsExact identifier
rxcui: 2723367

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
103db7f1-8540-4bea-935e-217d69e7aa011 ML zopapogene imadenovec-drba 500000000000 UNT/ML InjectionSCD4These highlights do not include all the information needed to use PAPZIMEOS™ safely and effectively. See full prescribing information for PAPZIMEOS. PAPZIMEOS (zopapogene imadenovec-drba) suspension for subcutaneous injection Initial U.S. Approval: 202520250812
103db7f1-8540-4bea-935e-217d69e7aa01zopapogene imadenovec-drba 500000000000 PU per 1 ML InjectionSY4These highlights do not include all the information needed to use PAPZIMEOS™ safely and effectively. See full prescribing information for PAPZIMEOS. PAPZIMEOS (zopapogene imadenovec-drba) suspension for subcutaneous injection Initial U.S. Approval: 202520250812
103db7f1-8540-4bea-935e-217d69e7aa01zopapogene imadenovec-drba 500,000,000,000 PU in 1 ML InjectionPSN4These highlights do not include all the information needed to use PAPZIMEOS™ safely and effectively. See full prescribing information for PAPZIMEOS. PAPZIMEOS (zopapogene imadenovec-drba) suspension for subcutaneous injection Initial U.S. Approval: 202520250812