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United States · US · US:71335-2066_9774fc12-2fd3-4928-8960-6a211eabfb68

Metaxalone

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    7133520661
    30 TABLET in 1 BOTTLE (71335-2066-1)
  • ndc11
    7133520662
    90 TABLET in 1 BOTTLE (71335-2066-2)
  • ndc11
    7133520663
    100 TABLET in 1 BOTTLE (71335-2066-3)
  • ndc11
    7133520664
    60 TABLET in 1 BOTTLE (71335-2066-4)
  • ndc11
    7133520665
    10 TABLET in 1 BOTTLE (71335-2066-5)
  • ndc11
    7133520666
    20 TABLET in 1 BOTTLE (71335-2066-6)
  • ndc11
    7133520667
    120 TABLET in 1 BOTTLE (71335-2066-7)
  • ndc11
    7133520668
    15 TABLET in 1 BOTTLE (71335-2066-8)

Annotations

UNII (FDA Substance ID)
1NMA9J598Y
METAXALONE
RxCUI 59078
Orange Book
A204770
AB
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": "71335-2066_9774fc12-2fd3-4928-8960-6a211eabfb68",
  "productndc": "71335-2066",
  "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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