United States· US:76420-898_4fa17239-3e4c-a50f-e063-6394a90a4de5

Metaxalone

A medicinal product containing metaxalone, registered in United States by Asclemed USA, Inc..

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:76420-898_4fa17239…PACKS LISTED14CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
METAXALONE
Manufacturer
Asclemed USA, Inc.
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 · 14

  • ndc11
    7642089801
    100 TABLET in 1 BOTTLE (76420-898-01)
  • ndc11
    7642089812
    12 TABLET in 1 BOTTLE (76420-898-12)
  • ndc11
    7642089815
    15 TABLET in 1 BOTTLE (76420-898-15)
  • ndc11
    7642089820
    20 TABLET in 1 BOTTLE (76420-898-20)
  • ndc11
    7642089830
    30 TABLET in 1 BOTTLE (76420-898-30)
  • ndc11
    7642089860
    60 TABLET in 1 BOTTLE (76420-898-60)
  • ndc11
    7642089890
    90 TABLET in 1 BOTTLE (76420-898-90)
  • ndc11
    76420-898-01
  • ndc11
    76420-898-12
  • ndc11
    76420-898-15
  • ndc11
    76420-898-20
  • ndc11
    76420-898-30
  • ndc11
    76420-898-60
  • ndc11
    76420-898-90

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/fba11169-e4a8-4559-89ca-da61cc4b84ee
GET /v1/drugs/fba11169-e4a8-4559-89ca-da61cc4b84ee?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": "76420-898",
  "dosage_form": "TABLET",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "ANDA203695",
  "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.