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United States · US · US:71335-0375_b97be1a8-3fbc-4207-b88e-18ed1f3ca33c
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 · 10
- ndc117133503750100 TABLET in 1 BOTTLE (71335-0375-0)
- ndc11713350375130 TABLET in 1 BOTTLE (71335-0375-1)
- ndc11713350375220 TABLET in 1 BOTTLE (71335-0375-2)
- ndc11713350375390 TABLET in 1 BOTTLE (71335-0375-3)
- ndc117133503754120 TABLET in 1 BOTTLE (71335-0375-4)
- ndc11713350375515 TABLET in 1 BOTTLE (71335-0375-5)
- ndc11713350375610 TABLET in 1 BOTTLE (71335-0375-6)
- ndc11713350375760 TABLET in 1 BOTTLE (71335-0375-7)
- ndc11713350375816 TABLET in 1 BOTTLE (71335-0375-8)
- ndc11713350375984 TABLET in 1 BOTTLE (71335-0375-9)
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": "71335-0375_b97be1a8-3fbc-4207-b88e-18ed1f3ca33c",
"productndc": "71335-0375",
"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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