ITVISMA

UNIISPLATC M09AX09

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

Identification

ManufacturerNovartis Gene Therapies, Inc.

CountryUS (United States)

ATC codeM09AX09

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7189420002
1 VIAL, SINGLE-DOSE in 1 CARTON (71894-200-02) / 3 mL in 1 VIAL, SINGLE-DOSE (71894-200-01)

Annotations

UNII (FDA Substance ID)

MLU3LU3EVV

ONASEMNOGENE ABEPARVOVEC

RxCUI 2170226

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "MLU3LU3EVV",
    "rxcui": "2170226",
    "inchikey": null,
    "display_name": "ONASEMNOGENE ABEPARVOVEC",
    "substance_type": "structurallyDiverse",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRATHECAL",
  "spl_meta": {
    "ab2e1c6c-4f95-4243-9296-1734e0a30591": {
      "match": "brand_token",
      "title": "ITVISMA (ONASEMNOGENE ABEPARVOVEC-BRVE) INJECTION, SUSPENSION [NOVARTIS GENE THERAPIES, INC.]",
      "spl_version": "1",
      "published_date": "2025-11-27"
    }
  },
  "productid": "71894-200_ab2e1c6c-4f95-4243-9296-1734e0a30591",
  "productndc": "71894-200",
  "dosage_form": "INJECTION, SUSPENSION",
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONASEMNOGENE ABEPARVOVEC",
  "proprietary_name": "ITVISMA",
  "active_ingred_unit": "[arb'U]/mL",
  "application_number": "BLA125856",
  "marketing_category": "BLA",
  "nonproprietary_name": "onasemnogene abeparvovec-brve",
  "start_marketing_date": "20251124",
  "active_numerator_strength": "40000000000000"
}

Related drugs

Other records sharing ATC code M09AX09.

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