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United States · US · US:68788-7765_b99d9d5e-909d-41fb-a904-c4113639c70c

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

  • ndc11
    6878877651
    100 TABLET in 1 BOTTLE (68788-7765-1)
  • ndc11
    6878877652
    20 TABLET in 1 BOTTLE (68788-7765-2)
  • ndc11
    6878877653
    30 TABLET in 1 BOTTLE (68788-7765-3)
  • ndc11
    6878877656
    60 TABLET in 1 BOTTLE (68788-7765-6)
  • ndc11
    6878877658
    120 TABLET in 1 BOTTLE (68788-7765-8)
  • ndc11
    6878877659
    90 TABLET in 1 BOTTLE (68788-7765-9)

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": "68788-7765_b99d9d5e-909d-41fb-a904-c4113639c70c",
  "productndc": "68788-7765",
  "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": "20200715",
  "active_numerator_strength": "500"
}

Related drugs

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