PAPZIMEOS

UNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPrecigen, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8476851101
1 POUCH in 1 CARTON (84768-511-01) / 1 VIAL in 1 POUCH / 1 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

C525BYS7TP

ZOPAPOGENE IMADENOVEC

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "C525BYS7TP",
    "rxcui": null,
    "inchikey": null,
    "display_name": "ZOPAPOGENE IMADENOVEC",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "103db7f1-8540-4bea-935e-217d69e7aa01": {
      "match": "brand_token",
      "title": "PAPZIMEOS (ZOPAPOGENE IMADENOVEC) INJECTION, SUSPENSION [PRECIGEN, INC.]",
      "spl_version": "4",
      "published_date": "2026-03-18"
    }
  },
  "productid": "84768-511_f1d461da-c962-444c-898a-c0c0aaca9faf",
  "productndc": "84768-511",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZOPAPOGENE IMADENOVEC",
  "proprietary_name": "PAPZIMEOS",
  "active_ingred_unit": "{VP}/mL",
  "application_number": "BLA125832",
  "marketing_category": "BLA",
  "nonproprietary_name": "zopapogene imadenovec",
  "start_marketing_date": "20250915",
  "active_numerator_strength": "500000000000"
}

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