Metaxalone

Orange BookUNIISPL

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

Identification

ManufacturerDoc Rx

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6930610001
100 TABLET in 1 BOTTLE (69306-100-01)
ndc11
6930610002
20 TABLET in 1 BOTTLE (69306-100-02)
ndc11
6930610003
30 TABLET in 1 BOTTLE (69306-100-03)
ndc11
6930610006
60 TABLET in 1 BOTTLE (69306-100-06)
ndc11
6930610009
90 TABLET in 1 BOTTLE (69306-100-09)
ndc11
6930610015
15 TABLET in 1 BOTTLE (69306-100-15)

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": "69306-100_cd0929e3-c3b2-c89a-e053-2a95a90a7b2a",
  "productndc": "69306-100",
  "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": "20190401",
  "active_numerator_strength": "800"
}

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