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United States · US · US:70954-785_49a8aa56-e193-4967-9257-bdfc8b0fa26a
Nabumetone
Orange BookUNIISPLATC M01AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeM01AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc117095478510100 TABLET, FILM COATED in 1 BOTTLE (70954-785-10)
- ndc117095478520500 TABLET, FILM COATED in 1 BOTTLE (70954-785-20)
Annotations
UNII (FDA Substance ID)
LW0TIW155Z
NABUMETONE
RxCUI 31448
Orange Book
A219118
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "LW0TIW155Z",
"rxcui": "31448",
"inchikey": "BLXXJMDCKKHMKV-UHFFFAOYSA-N",
"display_name": "NABUMETONE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e87289f4-d4f9-4510-aaa5-51f8f8167658": {
"match": "brand_token",
"title": "NABUMETONE TABLET, FILM COATED [ANI PHARMACEUTICALS, INC.]",
"spl_version": "2",
"published_date": "2026-06-01"
}
},
"productid": "70954-785_49a8aa56-e193-4967-9257-bdfc8b0fa26a",
"productndc": "70954-785",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "219118",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jan 7, 2025"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "002",
"approval_date": "Jan 7, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NABUMETONE",
"proprietary_name": "Nabumetone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA219118",
"marketing_category": "ANDA",
"nonproprietary_name": "Nabumetone",
"start_marketing_date": "20250107",
"active_numerator_strength": "750"
}Related drugs
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