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United States · US · US:72789-028_2d58ab65-a0e3-e2a2-e063-6294a90a0e4a

Metaxalone

Orange BookUNIISPL

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7278902815
    15 TABLET in 1 BOTTLE, PLASTIC (72789-028-15)
  • ndc11
    7278902830
    30 TABLET in 1 BOTTLE, PLASTIC (72789-028-30)

Annotations

UNII (FDA Substance ID)
1NMA9J598Y
METAXALONE
RxCUI 59078
Orange Book
A207466
ABAB
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": "72789-028_2d58ab65-a0e3-e2a2-e063-6294a90a0e4a",
  "productndc": "72789-028",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207466",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "001",
        "approval_date": "Aug 31, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "002",
        "approval_date": "Mar 13, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METAXALONE",
  "proprietary_name": "Metaxalone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207466",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metaxalone",
  "start_marketing_date": "20170831",
  "active_numerator_strength": "800"
}

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