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United States · US · US:80425-0580_4face2dd-755d-77a0-e063-6294a90a32d5
Metaxalone
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAdvanced Rx of Tennessee, LLC
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11804250580130 TABLET in 1 BOTTLE (80425-0580-1)
- ndc11804250580260 TABLET in 1 BOTTLE (80425-0580-2)
- ndc11804250580390 TABLET in 1 BOTTLE (80425-0580-3)
Annotations
UNII (FDA Substance ID)
1NMA9J598Y
METAXALONE
RxCUI 59078
Orange Book
A207466
ABAB
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": "80425-0580_4face2dd-755d-77a0-e063-6294a90a32d5",
"productndc": "80425-0580",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "207466",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "800MG",
"product_no": "001",
"approval_date": "Aug 31, 2017"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "400MG",
"product_no": "002",
"approval_date": "Mar 13, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "METAXALONE",
"proprietary_name": "Metaxalone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA207466",
"marketing_category": "ANDA",
"nonproprietary_name": "Metaxalone",
"start_marketing_date": "20260417",
"active_numerator_strength": "800"
}Access this data programmatically
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