Metaxalone

Orange BookUNIISPL

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

Identification

ManufacturerPreferred Pharmaceuticals, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6878876750
15 TABLET in 1 BOTTLE (68788-7675-0)
ndc11
6878876751
100 TABLET in 1 BOTTLE (68788-7675-1)
ndc11
6878876752
20 TABLET in 1 BOTTLE (68788-7675-2)
ndc11
6878876753
30 TABLET in 1 BOTTLE (68788-7675-3)
ndc11
6878876756
60 TABLET in 1 BOTTLE (68788-7675-6)
ndc11
6878876759
90 TABLET in 1 BOTTLE (68788-7675-9)

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": "68788-7675_c7c7181f-dcf4-455a-8167-abc4ee482cb0",
  "productndc": "68788-7675",
  "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": "20200302",
  "active_numerator_strength": "800"
}

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