febuxostat

Orange BookUNIISPLATC M04AA03

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

Identification

ManufacturerNuCare Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeM04AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6807137609
90 TABLET in 1 BOTTLE (68071-3760-9)

Annotations

UNII (FDA Substance ID)

101V0R1N2E

FEBUXOSTAT

RxCUI 73689

Orange Book

A205443

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "101V0R1N2E",
    "rxcui": "73689",
    "inchikey": "BQSJTQLCZDPROO-UHFFFAOYSA-N",
    "display_name": "FEBUXOSTAT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f2c338dc-5bab-49f4-a4ac-d8dea8afeea5": {
      "match": "brand_token",
      "title": "FEBUXOSTAT TABLET [REMEDYREPACK INC.]",
      "spl_version": "1",
      "published_date": "2026-04-28"
    }
  },
  "productid": "68071-3760_2b5d52a3-c025-680f-e063-6394a90aca3f",
  "productndc": "68071-3760",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205443",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Jan 9, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Jan 9, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FEBUXOSTAT",
  "proprietary_name": "febuxostat",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205443",
  "marketing_category": "ANDA",
  "nonproprietary_name": "febuxostat",
  "start_marketing_date": "20230331",
  "active_numerator_strength": "40"
}

Related drugs

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