FDA.reportPublic FDA data

PAPZIMEOS

Product NDC
84768-511
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

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
application number: BLA125832
ndc (product): 84768-511

Additional Listing Data#

Finished product
Yes
Brand name base
PAPZIMEOS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZOPAPOGENE IMADENOVEC500000000000 {VP}/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C525BYS7TPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2723367Internal RxNorm lookup
2723374Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103db7f1-8540-4bea-935e-217d69e7aa01Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84768-511-01PAPZIMEOS1 in 1 POUCHINJECTION, SUSPENSION14
84768-511-01PAPZIMEOS1 in 1 CARTONINJECTION, SUSPENSION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
84768-511-01ML - Milliliter84768-511918ae074-c3ff-415d-b564-eb23db16d03112025-10-14

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125832PAPZIMEOSzopapogene imadenovec-drba351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723374Papzimeos 500,000,000,000 PU in 1 ML InjectionPSN103db7f1-8540-4bea-935e-217d69e7aa014
2723367zopapogene imadenovec-drba 500,000,000,000 PU in 1 ML InjectionPSN103db7f1-8540-4bea-935e-217d69e7aa014
27233741 ML zopapogene imadenovec-drba 500000000000 UNT/ML Injection [Papzimeos]SBD103db7f1-8540-4bea-935e-217d69e7aa014
27233671 ML zopapogene imadenovec-drba 500000000000 UNT/ML InjectionSCD103db7f1-8540-4bea-935e-217d69e7aa014
2723374Papzimeos 500000000000 PU per 1 ML InjectionSY103db7f1-8540-4bea-935e-217d69e7aa014
2723367zopapogene imadenovec-drba 500000000000 PU per 1 ML InjectionSY103db7f1-8540-4bea-935e-217d69e7aa014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84768-511-01847680511011 POUCH in 1 CARTON (84768-511-01) / 1 VIAL in 1 POUCH / 1 mL in 1 VIAL1 pouch2025-09-15NoNoCurrent