United States· US:0078-1189_f0bead0e-4eed-4db9-a076-1d974eba6b4a
FABHALTA
A medicinal product containing iptacopan, 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
- iptacopan
- 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 12, 2026
Packs & prices · 1
- ndc11007811892060 CAPSULE in 1 BOTTLE (0078-1189-20)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Iptacopan in 14 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaFABHALTANovartis Europharm Limited, Dublin
- SwitzerlandFabhalta
- SpainFABHALTA 200 MG CAPSULAS DURASNovartis Europharm Limited
- FinlandFABHALTANovartis Europharm Limited
- FranceFABHALTA 200 mg, géluleNOVARTIS EUROPHARM (IRLANDE)
- BelgiumFabhalta 200 mgNovartis Europharm
- IrelandFABHALTA 200 mg hard capsulesNovartis Europharm Limited
- IcelandFabhaltaNovartis Europharm Limited*
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Fabhalta
- Liechtenstein · Fabhalta
- Norway · Fabhalta
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/8579753c-006e-43b5-a700-d12c073910ef GET /v1/drugs/8579753c-006e-43b5-a700-d12c073910ef?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": "ORAL",
"livertox": {
"summary": null,
"livertox_id": null,
"hepatotoxicity_score": null
},
"productid": "0078-1189_f0bead0e-4eed-4db9-a076-1d974eba6b4a",
"productndc": "0078-1189",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IPTACOPAN HYDROCHLORIDE",
"proprietary_name": "FABHALTA",
"active_ingred_unit": "mg/1",
"application_number": "NDA218276",
"marketing_category": "NDA",
"nonproprietary_name": "iptacopan",
"start_marketing_date": "20231205",
"active_numerator_strength": "200"
}See everything about iptacopan.
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.