United States· US:64380-189_4bb0aa92-80d2-4cbc-9261-012f3b5eb1c1
Zileuton
A medicinal product containing zileuton, registered in United States by Strides Pharma Science Limited.
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
- ZILEUTON
- Manufacturer
- Strides Pharma Science Limited
- 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
- ndc116438018901120 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (64380-189-01)
- ndc1164380-189-01
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Zileuton in 1 other country
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/e4770c19-8222-46b0-a91a-2cd5033b4615 GET /v1/drugs/e4770c19-8222-46b0-a91a-2cd5033b4615?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": "600",
"substance": "ZILEUTON",
"productndc": "64380-189",
"dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA212670",
"marketing_category": "ANDA"
}See everything about zileuton.
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.