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United States · US · US:76420-232_e49bafe5-839d-17b7-e053-2a95a90a64d9
Metaxalone
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11764202322020 TABLET in 1 BOTTLE (76420-232-20)
- ndc11764202323030 TABLET in 1 BOTTLE (76420-232-30)
- ndc11764202326060 TABLET in 1 BOTTLE (76420-232-60)
- ndc11764202329090 TABLET in 1 BOTTLE (76420-232-90)
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": "76420-232_e49bafe5-839d-17b7-e053-2a95a90a64d9",
"productndc": "76420-232",
"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"
}Access this data programmatically
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