United States· US:80425-0084_2a990578-5a3d-aeda-e063-6294a90af6fb

Metaxalone

A medicinal product containing metaxalone, registered in United States by Advanced Rx of Tennessee, LLC.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedMetaxaloneATC—REGISTER NO.US:80425-0084_2a99057…PACKS LISTED4CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
METAXALONE
Manufacturer
Advanced Rx of Tennessee, 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 · 4

  • ndc11
    8042500842
    60 TABLET in 1 BOTTLE (80425-0084-2)
  • ndc11
    8042500843
    90 TABLET in 1 BOTTLE (80425-0084-3)
  • ndc11
    80425-0084-2
  • ndc11
    80425-0084-3

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/fcd32d14-4403-43d2-9787-7fcf24cdb7a5
GET /v1/drugs/fcd32d14-4403-43d2-9787-7fcf24cdb7a5?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": "80425-0084",
  "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.