United States· US:71894-128_f1dde092-6024-41c8-8006-77e19ef21ec1
Zolgensma
A medicinal product containing onasemnogene abeparvovec-xioi, registered in United States by Novartis Gene Therapies, Inc..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- onasemnogene abeparvovec-xioi
- Manufacturer
- Novartis Gene Therapies, Inc.
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- June 3, 2026
Packs & prices · 1
- ndc1171894128051 KIT in 1 CARTON (71894-128-05) * 8.3 mL in 1 VIAL (71894-115-01) * 1 mL in 1 POUCH * 5.5 mL in 1 VIAL (71894-110-01)
Regulatory notes
Same medicine, other countries
Onasemnogene abeparvovec-xioi in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaITVISMANovartis Europharm Limited, Dublin
- BelgiumItvisma 1.2 10*14 vgNovartis Europharm
- United KingdomZolgensma 20 tera vector genomes/ml (patient weight 10.1-10.5kg) solution for infusion 7 x 8.3ml vialsNovartis Pharmaceuticals UK Ltd
- Japanオナセムノゲン アベパルボベクノバルティス ファーマ
- NetherlandsItvisma 1,2 × 1014 vectorgenomen oplossing voor injectieNovartis Europharm Limited
- FinlandItvismaNovartis Europharm Limited
- PolandItvismaNovartis Europharm Limited
- SwedenItvisma 1,2 x 10E14 vektorgenom Injektionsvätska, lösningNovartis Europharm Limited
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Itvisma, Zolgensma
- Liechtenstein · Itvisma, Zolgensma
- Norway · Itvisma, Zolgensma
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/df48b91f-ae8f-451e-b55c-5495429e2939 GET /v1/drugs/df48b91f-ae8f-451e-b55c-5495429e2939?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"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": "71894-128_f1dde092-6024-41c8-8006-77e19ef21ec1",
"productndc": "71894-128",
"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
}See everything about onasemnogene abeparvovec-xioi.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.