Metaxalone

Orange BookUNIISPL

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133509580
100 TABLET in 1 BOTTLE (71335-0958-0)
ndc11
7133509581
30 TABLET in 1 BOTTLE (71335-0958-1)
ndc11
7133509582
20 TABLET in 1 BOTTLE (71335-0958-2)
ndc11
7133509583
90 TABLET in 1 BOTTLE (71335-0958-3)
ndc11
7133509584
120 TABLET in 1 BOTTLE (71335-0958-4)
ndc11
7133509585
15 TABLET in 1 BOTTLE (71335-0958-5)
ndc11
7133509586
10 TABLET in 1 BOTTLE (71335-0958-6)
ndc11
7133509587
60 TABLET in 1 BOTTLE (71335-0958-7)
ndc11
7133509588
16 TABLET in 1 BOTTLE (71335-0958-8)
ndc11
7133509589
84 TABLET in 1 BOTTLE (71335-0958-9)

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": "71335-0958_d884568c-4c86-428f-958a-16367089c4ad",
  "productndc": "71335-0958",
  "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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