Metaxalone

Orange BookUNIISPL

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

Identification

ManufacturerINA Pharmaceutics Inc

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7415701860
60 TABLET in 1 BOTTLE (74157-018-60)

Annotations

UNII (FDA Substance ID)

1NMA9J598Y

METAXALONE

RxCUI 59078

Orange Book

N022503

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": "74157-018_4a02d857-976b-b4c7-e063-6294a90a655b",
  "productndc": "74157-018",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "022503",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jun 1, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METAXALONE",
  "proprietary_name": "Metaxalone",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022503",
  "marketing_category": "NDA",
  "nonproprietary_name": "Metaxalone",
  "start_marketing_date": "20250210",
  "active_numerator_strength": "640"
}

Access this data programmatically

Query Metaxalone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs