Nabumetone

Orange BookUNIISPLATC M01AX01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeM01AX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7120597800
100 TABLET in 1 BOTTLE, PLASTIC (71205-978-00)
ndc11
7120597830
30 TABLET in 1 BOTTLE, PLASTIC (71205-978-30)
ndc11
7120597855
500 TABLET in 1 BOTTLE, PLASTIC (71205-978-55)
ndc11
7120597860
60 TABLET in 1 BOTTLE, PLASTIC (71205-978-60)
ndc11
7120597872
120 TABLET in 1 BOTTLE, PLASTIC (71205-978-72)
ndc11
7120597890
90 TABLET in 1 BOTTLE, PLASTIC (71205-978-90)

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": "71205-978_40ce485f-575c-4c51-8058-83b10a8ddac7",
  "productndc": "71205-978",
  "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": "20190925",
  "active_numerator_strength": "750"
}

Related drugs

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