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United States · US · US:71894-134_f1dde092-6024-41c8-8006-77e19ef21ec1

Zolgensma

SPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNovartis Gene Therapies, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7189413407
    1 KIT in 1 CARTON (71894-134-07) * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH * 5.5 mL in 1 VIAL (71894-110-01)

Annotations

DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "68cd4f06-70e1-40d8-bedb-609ec0afa471": {
      "match": "brand_token",
      "title": "ZOLGENSMA (ONASEMNOGENE ABEPARVOVEC-XIOI) KIT [NOVARTIS GENE THERAPIES, INC.]",
      "spl_version": "14",
      "published_date": "2025-12-19"
    }
  },
  "productid": "71894-134_f1dde092-6024-41c8-8006-77e19ef21ec1",
  "productndc": "71894-134",
  "dosage_form": "KIT",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Zolgensma",
  "active_ingred_unit": null,
  "application_number": "BLA125694",
  "marketing_category": "BLA",
  "nonproprietary_name": "onasemnogene abeparvovec-xioi",
  "start_marketing_date": "20190524",
  "active_numerator_strength": null
}

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