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United States · US · US:76420-210_d9ae8825-f28b-ba4e-e053-2995a90a4487

Nabumetone

Orange BookUNIISPLATC M01AX01

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

Identification

ManufacturerAsclemed USA, Inc.
CountryUS (United States)
ATC codeM01AX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    7642021007
    7 TABLET in 1 BOTTLE (76420-210-07)
  • ndc11
    7642021010
    10 TABLET in 1 BOTTLE (76420-210-10)
  • ndc11
    7642021014
    14 TABLET in 1 BOTTLE (76420-210-14)
  • ndc11
    7642021020
    20 TABLET in 1 BOTTLE (76420-210-20)
  • ndc11
    7642021030
    30 TABLET in 1 BOTTLE (76420-210-30)
  • ndc11
    7642021060
    60 TABLET in 1 BOTTLE (76420-210-60)

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": "76420-210_d9ae8825-f28b-ba4e-e053-2995a90a4487",
  "productndc": "76420-210",
  "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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