🇺🇸
United States · US · US:68788-7018_bb833f5d-c5dd-41de-afa3-c701da794415
Metaxalone
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc116878870180100 TABLET in 1 BOTTLE (68788-7018-0)
- ndc11687887018115 TABLET in 1 BOTTLE (68788-7018-1)
- ndc11687887018220 TABLET in 1 BOTTLE (68788-7018-2)
- ndc11687887018330 TABLET in 1 BOTTLE (68788-7018-3)
- ndc11687887018660 TABLET in 1 BOTTLE (68788-7018-6)
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": "68788-7018_bb833f5d-c5dd-41de-afa3-c701da794415",
"productndc": "68788-7018",
"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": "20171011",
"active_numerator_strength": "800"
}Access this data programmatically
Query Metaxalone and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.