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United States · US · US:76282-257_11f0008a-dff5-4fd3-8f48-76d033ea87f5

Nabumetone

Orange BookUNIISPLATC M01AX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerExelan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeM01AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7628225701
    100 TABLET, FILM COATED in 1 BOTTLE (76282-257-01)
  • ndc11
    7628225705
    500 TABLET, FILM COATED in 1 BOTTLE (76282-257-05)

Annotations

UNII (FDA Substance ID)
LW0TIW155Z
NABUMETONE
RxCUI 31448
Orange Book
A078671
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": "76282-257_11f0008a-dff5-4fd3-8f48-76d033ea87f5",
  "productndc": "76282-257",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078671",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Mar 7, 2008"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Mar 7, 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": "ANDA078671",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nabumetone",
  "start_marketing_date": "20150414",
  "active_numerator_strength": "500"
}

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