United States· US:64406-030_4473196a-b991-4580-b3d4-dbe24f8fe414
ZURZUVAE
A zuranolone product containing zuranolone, registered in United States by Biogen MA Inc.. The same ATC class is registered in 8 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Zuranolone is registered in 8 of 19 countries.
Countries holding a registration under ATC N06AX31 (zuranolone), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 5 of them publish a price we can compare per daily dose
Zuranolone · ATC N06AX31
8 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Icelandprice
- Ireland
- Netherlands
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- ZURANOLONE
- Manufacturer
- Biogen MA Inc.
- Country
- United States (US)
- ATC code
- N06AX31
- ATC class
- Zuranolone
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1164406-030-02
- ndc1164406-030-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Zuranolone in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaZURZUVAEBiogen Netherlands B.V., Badhoevedorp
- FinlandZurzuvaeBiogen Netherlands B.V.
- IrelandZurzuvae 25 mg hard capsulesBiogen Netherlands B.V.
- IcelandZurzuvaeBiogen Netherlands B.V.
- NetherlandsZurzuvae 25 mg harde capsulesBiogen Netherlands B.V.
- PolandZurzuvaeBiogen Netherlands B.V.
- SwedenZurzuvae 25 mg Kapsel, hårdBiogen Netherlands B.V.
- BelgiumZurzuvae 25 mgBiogen Netherlands
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Zurzuvae
- Liechtenstein · Zurzuvae
- Norway · Zurzuvae
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/92ebbd88-820a-4d2b-983a-9f6a4ed6e3c3 GET /v1/drugs/92ebbd88-820a-4d2b-983a-9f6a4ed6e3c3?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",
"source": "ndc",
"strength": "25",
"substance": "ZURANOLONE",
"productndc": "64406-030",
"dosage_form": "CAPSULE",
"dea_schedule": "CIV",
"strength_unit": "mg/1",
"application_number": "NDA217369",
"marketing_category": "NDA"
}See everything about zuranolone.
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.