United States· US:53746-553_b3ba9f93-52d6-4287-9e28-92059e0bf18b
Metaxalone
A medicinal product containing metaxalone, registered in United States by Amneal Pharmaceuticals of New York LLC.
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
- METAXALONE
- Manufacturer
- Amneal Pharmaceuticals of New York LLC
- 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 · 6
- ndc115374655301100 TABLET in 1 BOTTLE (53746-553-01)
- ndc115374655305500 TABLET in 1 BOTTLE (53746-553-05)
- ndc11537465533030 TABLET in 1 BOTTLE (53746-553-30)
- ndc1153746-553-01
- ndc1153746-553-05
- ndc1153746-553-30
Regulatory notes
No shortage, Orange Book or US label notes for this record.
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/e07e7644-42a5-4306-97b5-6da85233bb17 GET /v1/drugs/e07e7644-42a5-4306-97b5-6da85233bb17?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": "800",
"substance": "METAXALONE",
"productndc": "53746-553",
"dosage_form": "TABLET",
"dea_schedule": null,
"strength_unit": "mg/1",
"application_number": "ANDA203399",
"marketing_category": "ANDA"
}See everything about metaxalone.
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.