Zolgensma

SPL

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

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
7189414711
1 KIT in 1 CARTON (71894-147-11) * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH

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": "71894-147_f1dde092-6024-41c8-8006-77e19ef21ec1",
  "productndc": "71894-147",
  "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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