Metaxalone

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAvPAK

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5026853015
50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-530-15) / 1 TABLET in 1 BLISTER PACK (50268-530-11)

Annotations

UNII (FDA Substance ID)

1NMA9J598Y

METAXALONE

RxCUI 59078

Orange Book

A203399

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "1NMA9J598Y",
    "rxcui": "59078",
    "inchikey": "IMWZZHHPURKASS-UHFFFAOYSA-N",
    "display_name": "METAXALONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "91432cd0-8404-8029-e053-2a95a90adc1b": {
      "match": "brand_token",
      "title": "METAXALONE TABLET [DIRECT_RX]",
      "spl_version": "2",
      "published_date": "2026-05-13"
    }
  },
  "productid": "50268-530_4481b1d7-8b54-035a-e063-6394a90ab23d",
  "productndc": "50268-530",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203399",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "001",
        "approval_date": "Jun 21, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METAXALONE",
  "proprietary_name": "Metaxalone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203399",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metaxalone",
  "start_marketing_date": "20150313",
  "active_numerator_strength": "800"
}

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