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United States · US · US:68788-7597_1f953669-46a2-42c0-999e-60f78dc641c8
Nabumetone
Orange BookUNIISPLATC M01AX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM01AX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc116878875971100 TABLET in 1 BOTTLE (68788-7597-1)
- ndc11687887597220 TABLET in 1 BOTTLE (68788-7597-2)
- ndc11687887597330 TABLET in 1 BOTTLE (68788-7597-3)
- ndc11687887597660 TABLET in 1 BOTTLE (68788-7597-6)
- ndc116878875978120 TABLET in 1 BOTTLE (68788-7597-8)
- ndc11687887597990 TABLET in 1 BOTTLE (68788-7597-9)
Annotations
UNII (FDA Substance ID)
LW0TIW155Z
NABUMETONE
RxCUI 31448
Orange Book
A078420
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": "68788-7597_1f953669-46a2-42c0-999e-60f78dc641c8",
"productndc": "68788-7597",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078420",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Sep 24, 2008"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "750MG",
"product_no": "002",
"approval_date": "Sep 24, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NABUMETONE",
"proprietary_name": "Nabumetone",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078420",
"marketing_category": "ANDA",
"nonproprietary_name": "Nabumetone",
"start_marketing_date": "20200213",
"active_numerator_strength": "750"
}Related drugs
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