United States· US:0078-0846_381f1ba3-f115-424f-9890-75eb06ab6666
KYMRIAH
A medicinal product containing tisagenlecleucel, registered in United States by Novartis Pharmaceuticals Corporation.
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
- TISAGENLECLEUCEL
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1100780846191 INJECTION, SUSPENSION in 1 BAG (0078-0846-19)
- ndc110078-0846-19
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Tisagenlecleucel in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- FranceKYMRIAH 1,2 x 1 000 000 - 6 x 100 000 000 cellules, dispersion pour perfusionNOVARTIS EUROPHARM (IRLANDE)
- CanadaKYMRIAHNOVARTIS PHARMACEUTICALS CANADA INC
- SwitzerlandKymriah, Zellsuspension zur InfusionNovartis Pharma Schweiz AG
- CzechiaKYMRIAHNovartis Europharm Limited, Dublin
- SpainKYMRIAH 1,2 x 10e6 - 6,0 x 10e8 celulas dispersion para perfusionNovartis Europharm Limited
- FinlandKymriahNovartis Europharm Limited
- United KingdomKymriah 1.2million-600million cells dispersion for infusion bagsNovartis Pharmaceuticals UK Ltd
- IcelandKymriahNovartis Europharm Limited*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Kymriah
- Liechtenstein · Kymriah
- Norway · Kymriah
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/8d0009bb-58a6-40f9-b599-7ed6ab1ab180 GET /v1/drugs/8d0009bb-58a6-40f9-b599-7ed6ab1ab180?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": "INTRAVENOUS",
"source": "ndc",
"strength": "2000000",
"substance": "TISAGENLECLEUCEL",
"productndc": "0078-0846",
"dosage_form": "INJECTION, SUSPENSION",
"dea_schedule": null,
"strength_unit": "1/1",
"application_number": "BLA125646",
"marketing_category": "BLA"
}See everything about tisagenlecleucel.
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.