HEMGENIX

SPL

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

Identification

ManufacturerCSL Behring

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0053019019
1 KIT in 1 CARTON (0053-0190-19) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01)

Annotations

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "route": null,
  "spl_meta": {
    "35b2db65-4c6c-4173-ab56-b2bca69193bd": {
      "match": "brand_token",
      "title": "HEMGENIX (ETRANACOGENE DEZAPARVOVEC) KIT [CSL BEHRING]",
      "spl_version": "8",
      "published_date": "2026-05-11"
    }
  },
  "productid": "0053-0190_46103596-b3c5-48d1-9c04-dc7619864ffa",
  "productndc": "0053-0190",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "HEMGENIX",
  "active_ingred_unit": null,
  "application_number": "BLA125772",
  "marketing_category": "BLA",
  "nonproprietary_name": "etranacogene dezaparvovec",
  "start_marketing_date": "20221122",
  "active_numerator_strength": null
}

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