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United States · US · US:72789-028_2d58ab65-a0e3-e2a2-e063-6294a90a0e4a
Metaxalone
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11727890281515 TABLET in 1 BOTTLE, PLASTIC (72789-028-15)
- ndc11727890283030 TABLET in 1 BOTTLE, PLASTIC (72789-028-30)
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": "72789-028_2d58ab65-a0e3-e2a2-e063-6294a90a0e4a",
"productndc": "72789-028",
"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": "20170831",
"active_numerator_strength": "800"
}Access this data programmatically
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