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United States · US · US:50228-474_2fa7c2d7-03c0-4f7e-aa18-d586e157e177
Metaxalone
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerScieGen Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150228474101000 TABLET in 1 BOTTLE (50228-474-10)
- ndc11502284743030 TABLET in 1 BOTTLE (50228-474-30)
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": "50228-474_2fa7c2d7-03c0-4f7e-aa18-d586e157e177",
"productndc": "50228-474",
"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": "20200430",
"active_numerator_strength": "400"
}Access this data programmatically
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