United States· US:64406-250_4fa5df55-d5bf-44d1-856e-937b48e69bb0
SKYCLARYS
A omaveloxolone product containing omaveloxolone, registered in United States by Biogen. The same ATC class is registered in 11 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Omaveloxolone is registered in 11 of 19 countries.
Countries holding a registration under ATC N07XX25 (omaveloxolone), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 7 of them publish a price we can compare per daily dose
Omaveloxolone · ATC N07XX25
11 / 19 countries
- Belgiumprice
- Czechiaprice
- Denmark
- Finlandprice
- Franceprice
- Icelandprice
- Ireland
- Netherlands
- Switzerlandprice
- United Kingdom
- United Statesprice
Price per daily dose
What a daily dose of omaveloxolone costs, country by country.
Normalised to the WHO defined daily dose (0.15 g), so markets compare like for like.
- 1 market with a comparable price for this class
- Public list prices, converted to USD at the rate date shown
Omaveloxolone · price per daily dose (0.15 g)
USD · FX 28 Sept 2026
- CH Switzerland$859.97
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- OMAVELOXOLONE
- Manufacturer
- Biogen
- Country
- United States (US)
- ATC code
- N07XX25
- ATC class
- Omaveloxolone
- Defined daily dose
- 0.15 g, O
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc11644062509090 CAPSULE in 1 BOTTLE (64406-250-90)
- ndc1164406-250-90
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Omaveloxolone in 12 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- CzechiaSKYCLARYSBiogen Netherlands B.V., Badhoevedorp
- SwitzerlandSkyclarys 50 mg, HartkapselnBiogen Switzerland AG
- FinlandSkyclarysBiogen Netherlands B.V.
- FranceSKYCLARYS 50 mg, géluleBIOGEN NETHERLANDS (PAYS-BAS)
- United KingdomSkyclarys 50mg capsulesBiogen Idec Ltd
- IrelandSkyclarys 50 mg hard capsulesBiogen Netherlands B.V.
- IcelandSkyclarysBiogen Netherlands B.V.
- NetherlandsSkyclarys 50 mg harde capsulesBiogen Netherlands B.V.
Authorised across Europe · EMA
The same active substance is authorised in 3 EEA countries. Names it is sold under:
- Iceland · Skyclarys
- Liechtenstein · Skyclarys
- Norway · Skyclarys
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/d56e4eed-2d6e-4d95-a890-eee39b8ecfc6 GET /v1/drugs/d56e4eed-2d6e-4d95-a890-eee39b8ecfc6?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": "50",
"substance": "OMAVELOXOLONE",
"productndc": "64406-250",
"dosage_form": "CAPSULE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "NDA216718",
"marketing_category": "NDA"
}See everything about omaveloxolone.
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.