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United States · US · US:63187-490_37b601ca-6b00-44c1-8b4c-f9e007190df0

Metaxalone

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6318749010
    10 TABLET in 1 BOTTLE (63187-490-10)
  • ndc11
    6318749030
    30 TABLET in 1 BOTTLE (63187-490-30)
  • ndc11
    6318749060
    60 TABLET in 1 BOTTLE (63187-490-60)
  • ndc11
    6318749090
    90 TABLET in 1 BOTTLE (63187-490-90)

Annotations

UNII (FDA Substance ID)
1NMA9J598Y
METAXALONE
RxCUI 59078
Orange Book
A203399
AB
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": "63187-490_37b601ca-6b00-44c1-8b4c-f9e007190df0",
  "productndc": "63187-490",
  "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": "20130531",
  "active_numerator_strength": "800"
}

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