FDA.reportPublic FDA data

Papzimeos 500000000000 PU per 1 ML Injection

RxCUI
2723374
RxNorm name
Papzimeos 500000000000 PU per 1 ML Injection
Display name
Papzimeos 500000000000 PU per 1 ML Injection
Full name
Papzimeos 500000000000 PU per 1 ML Injection
Term type
SY
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)Rx2026-09-01

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
PAPZIMEOSZOPAPOGENE IMADENOVECPrecigen, Inc.103db7f1-8540-4bea-935e-217d69e7aa012025-08-12Warnings, Adverse reactionsExact identifier
rxcui: 2723374

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
103db7f1-8540-4bea-935e-217d69e7aa01Papzimeos 500,000,000,000 PU in 1 ML Injection [PSN] · 1 ML zopapogene imadenovec-drba 500000000000 UNT/ML Injection [Papzimeos] [SBD] · Papzimeos 500000000000 PU per 1 ML Injection [SY]34These 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