Home NDC 84768-511-01 PAPZIMEOS
Product NDC 84768-511
Requested package NDC 84768-511-01
11-digit product format 847680511
Labeler code 84768
Product ID 84768-511_f1d461da-c962-444c-898a-c0c0aaca9faf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name zopapogene imadenovec
Dosage form INJECTION, SUSPENSION
Route SUBCUTANEOUS
Labeler Precigen, Inc.
Application BLA125832
Marketing category BLA
Marketing start 2025-09-15
Substance ZOPAPOGENE IMADENOVEC
Active strength 500000000000 {VP}/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PAPZIMEOS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZOPAPOGENE IMADENOVEC 500000000000 {VP}/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C525BYS7TP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2723367 Internal RxNorm lookup 2723374 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84768-511-01 PAPZIMEOS 1 in 1 POUCH INJECTION, SUSPENSION 1 4 84768-511-01 PAPZIMEOS 1 in 1 CARTON INJECTION, SUSPENSION 1 4
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.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125832 PAPZIMEOS zopapogene imadenovec-drba 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84768-511-01 84768051101 1 POUCH in 1 CARTON (84768-511-01) / 1 VIAL in 1 POUCH / 1 mL in 1 VIAL 1 pouch 2025-09-15 No No Current