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United States · US · US:63629-8014_1ef2ad5e-9806-44ab-9760-b73ebd2084cc
Metaxalone
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 8
- ndc11636298014130 TABLET in 1 BOTTLE (63629-8014-1)
- ndc11636298014290 TABLET in 1 BOTTLE (63629-8014-2)
- ndc116362980143100 TABLET in 1 BOTTLE (63629-8014-3)
- ndc11636298014460 TABLET in 1 BOTTLE (63629-8014-4)
- ndc11636298014510 TABLET in 1 BOTTLE (63629-8014-5)
- ndc11636298014620 TABLET in 1 BOTTLE (63629-8014-6)
- ndc116362980147120 TABLET in 1 BOTTLE (63629-8014-7)
- ndc11636298014815 TABLET in 1 BOTTLE (63629-8014-8)
Annotations
UNII (FDA Substance ID)
1NMA9J598Y
METAXALONE
RxCUI 59078
Orange Book
A203695
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": "63629-8014_1ef2ad5e-9806-44ab-9760-b73ebd2084cc",
"productndc": "63629-8014",
"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"
}Access this data programmatically
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