FEBUXOSTAT

Orange BookUNIISPLATC M04AA03

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

Identification

ManufacturerSolco Healthcare US LLC

CountryUS (United States)

ATC codeM04AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4354729603
30 TABLET in 1 BOTTLE (43547-296-03)
ndc11
4354729609
90 TABLET in 1 BOTTLE (43547-296-09)
ndc11
4354729650
500 TABLET in 1 BOTTLE (43547-296-50)

Annotations

UNII (FDA Substance ID)

101V0R1N2E

FEBUXOSTAT

RxCUI 73689

Orange Book

A206266

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": "43547-296_7125d234-570f-4c51-8e72-8202f4dc299b",
  "productndc": "43547-296",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206266",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Mar 28, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FEBUXOSTAT",
  "proprietary_name": "FEBUXOSTAT",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206266",
  "marketing_category": "ANDA",
  "nonproprietary_name": "febuxostat",
  "start_marketing_date": "20230801",
  "active_numerator_strength": "80"
}

Related drugs

Other records sharing ATC code M04AA03.

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