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 · 7

ndc11
8576601101
100 TABLET in 1 BOTTLE (85766-011-01)
ndc11
8576601112
12 TABLET in 1 BOTTLE (85766-011-12)
ndc11
8576601115
15 TABLET in 1 BOTTLE (85766-011-15)
ndc11
8576601120
20 TABLET in 1 BOTTLE (85766-011-20)
ndc11
8576601130
30 TABLET in 1 BOTTLE (85766-011-30)
ndc11
8576601160
60 TABLET in 1 BOTTLE (85766-011-60)
ndc11
8576601190
90 TABLET in 1 BOTTLE (85766-011-90)

Annotations

UNII (FDA Substance ID)

1NMA9J598Y

METAXALONE

RxCUI 59078

Orange Book

A203695

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": "85766-011_49eed194-0dfa-5136-e063-6394a90a88e4",
  "productndc": "85766-011",
  "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": "20170619",
  "active_numerator_strength": "800"
}

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