Metaxalone

Orange BookUNIISPL

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

Identification

ManufacturerSportpharm LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
8576614301
100 TABLET in 1 BOTTLE (85766-143-01)
ndc11
8576614306
6 TABLET in 1 BOTTLE (85766-143-06)
ndc11
8576614312
12 TABLET in 1 BOTTLE (85766-143-12)
ndc11
8576614315
15 TABLET in 1 BOTTLE (85766-143-15)
ndc11
8576614320
20 TABLET in 1 BOTTLE (85766-143-20)
ndc11
8576614330
30 TABLET in 1 BOTTLE (85766-143-30)
ndc11
8576614360
60 TABLET in 1 BOTTLE (85766-143-60)
ndc11
8576614390
90 TABLET in 1 BOTTLE (85766-143-90)

Annotations

UNII (FDA Substance ID)

1NMA9J598Y

METAXALONE

RxCUI 59078

Orange Book

A204770

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": "85766-143_4eb1c8ee-001a-5379-e063-6294a90a2fac",
  "productndc": "85766-143",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "204770",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "001",
        "approval_date": "Nov 22, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METAXALONE",
  "proprietary_name": "Metaxalone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204770",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Metaxalone",
  "start_marketing_date": "20161122",
  "active_numerator_strength": "800"
}

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