Nabumetone 500 mg

Orange BookUNIISPLATC M01AX01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerLGM PHARMA SOLUTIONS, LLC

CountryUS (United States)

ATC codeM01AX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7973970761
100 TABLET, FILM COATED in 1 BOTTLE (79739-7076-1)
ndc11
7973970765
500 TABLET, FILM COATED in 1 BOTTLE (79739-7076-5)

Annotations

UNII (FDA Substance ID)

LW0TIW155Z

NABUMETONE

RxCUI 31448

Orange Book

A203166

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": "79739-7076_cf52d275-4853-4576-832a-07630bb644dc",
  "productndc": "79739-7076",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203166",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Aug 30, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "002",
        "approval_date": "Aug 30, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "1GM",
        "product_no": "003",
        "approval_date": "Aug 30, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NABUMETONE",
  "proprietary_name": "Nabumetone 500 mg",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203166",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nabumetone",
  "start_marketing_date": "20190904",
  "active_numerator_strength": "500"
}

Related drugs

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