United States· US:68083-501_57566e6e-e90a-4fdf-b23c-d8af19893fd2
edaravone
A edaravone product containing edaravone, registered in United States by Gland Pharma Limited. The same ATC class is registered in 3 of our 19 countries.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
Where it is registered
Edaravone is registered in 3 of 19 countries.
Countries holding a registration under ATC N07XX14 (edaravone), each read from that country’s own register.
- This record: United States, from FDA National Drug Code directory (United States)
- 2 of them publish a price we can compare per daily dose
Edaravone · ATC N07XX14
3 / 19 countries
- Canada
- Switzerlandprice
- United Statesprice
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- EDARAVONE
- Manufacturer
- Gland Pharma Limited
- Country
- United States (US)
- ATC code
- N07XX14
- ATC class
- Edaravone
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1168083-501-01
- ndc1168083501011 POUCH in 1 CARTON (68083-501-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Edaravone in 2 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
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/44741a12-b01f-4709-96ce-91ad754136f8 GET /v1/drugs/44741a12-b01f-4709-96ce-91ad754136f8?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": "60",
"substance": "EDARAVONE",
"productndc": "68083-501",
"dosage_form": "INJECTION, SOLUTION",
"dea_schedule": null,
"strength_unit": "mg/100mL",
"application_number": "ANDA216199",
"marketing_category": "ANDA"
}See everything about edaravone.
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.