Metaxalone

Orange BookUNIISPL

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
7642089801
100 TABLET in 1 BOTTLE (76420-898-01)
ndc11
7642089812
12 TABLET in 1 BOTTLE (76420-898-12)
ndc11
7642089815
15 TABLET in 1 BOTTLE (76420-898-15)
ndc11
7642089820
20 TABLET in 1 BOTTLE (76420-898-20)
ndc11
7642089830
30 TABLET in 1 BOTTLE (76420-898-30)
ndc11
7642089860
60 TABLET in 1 BOTTLE (76420-898-60)
ndc11
7642089890
90 TABLET in 1 BOTTLE (76420-898-90)

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": "76420-898_4fa17239-3e4c-a50f-e063-6394a90a4de5",
  "productndc": "76420-898",
  "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": "20170619",
  "active_numerator_strength": "800"
}

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