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United States · US · US:51655-446_4b444a44-63fe-1d97-e063-6294a90a6cc8

Nabumetone

Orange BookUNIISPLATC M01AX01

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

Identification

ManufacturerNorthwind Health Company, LLC
CountryUS (United States)
ATC codeM01AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5165544620
    20 TABLET in 1 BOTTLE, PLASTIC (51655-446-20)
  • ndc11
    5165544625
    60 TABLET in 1 BOTTLE, PLASTIC (51655-446-25)
  • ndc11
    5165544652
    30 TABLET in 1 BOTTLE, PLASTIC (51655-446-52)
  • ndc11
    5165544684
    14 TABLET in 1 BOTTLE, PLASTIC (51655-446-84)

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": "51655-446_4b444a44-63fe-1d97-e063-6294a90a6cc8",
  "productndc": "51655-446",
  "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": "20201002",
  "active_numerator_strength": "500"
}

Related drugs

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