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United States · US · US:72162-1557_c8232f1d-ead4-4e07-9731-dd0b9265f736

Nabumetone

Orange BookUNIISPLATC M01AX01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM01AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7216215571
    100 TABLET in 1 BOTTLE (72162-1557-1)
  • ndc11
    7216215575
    500 TABLET in 1 BOTTLE (72162-1557-5)

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": "72162-1557_c8232f1d-ead4-4e07-9731-dd0b9265f736",
  "productndc": "72162-1557",
  "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": "20190626",
  "active_numerator_strength": "500"
}

Related drugs

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