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United States· US:68788-7018_bb833f5d-c5dd-41de-afa3-c701da794415

Metaxalone

A medicinal product containing metaxalone, registered in United States by Preferred Pharmaceuticals Inc..

Orange BookUS 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:68788-7018_bb833f5…PACKS LISTED5CHECKEDSeptember 12, 2026
Compare price across countriesPer daily dose · free accountAsk the assistant about metaxaloneAnswers with sources · free accountCheck interactionsSeverity free · mechanism on Growth

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
Metaxalone
Manufacturer
Preferred Pharmaceuticals 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 12, 2026

Packs & prices · 5

  • ndc11
    6878870180
    100 TABLET in 1 BOTTLE (68788-7018-0)
  • ndc11
    6878870181
    15 TABLET in 1 BOTTLE (68788-7018-1)
  • ndc11
    6878870182
    20 TABLET in 1 BOTTLE (68788-7018-2)
  • ndc11
    6878870183
    30 TABLET in 1 BOTTLE (68788-7018-3)
  • ndc11
    6878870186
    60 TABLET in 1 BOTTLE (68788-7018-6)

Regulatory notes

UNII (FDA substance ID)
1NMA9J598Y
METAXALONE
RxCUI 59078
Orange Book
A203695
AB
DailyMed SPL labels
1 version tracked

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/e459db00-300d-4e3f-b94f-f3bc5537259a
GET /v1/drugs/e459db00-300d-4e3f-b94f-f3bc5537259a?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.

{
  "unii": {
    "unii": "1NMA9J598Y",
    "rxcui": "59078",
    "inchikey": "IMWZZHHPURKASS-UHFFFAOYSA-N",
    "display_name": "METAXALONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "livertox": {
    "summary": null,
    "livertox_id": null,
    "hepatotoxicity_score": 5
  },
  "spl_meta": {
    "91432cd0-8404-8029-e053-2a95a90adc1b": {
      "match": "brand_token",
      "title": "METAXALONE TABLET [DIRECT_RX]",
      "spl_version": "2",
      "published_date": "2026-05-13"
    }
  },
  "productid": "68788-7018_bb833f5d-c5dd-41de-afa3-c701da794415",
  "productndc": "68788-7018",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203695",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "001",
        "approval_date": "Jun 15, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METAXALONE",
  "proprietary_name": "Metaxalone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203695",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metaxalone",
  "start_marketing_date": "20171011",
  "active_numerator_strength": "800"
}
API referenceMCP serverPlans

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.

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