Febuxostat

Orange BookUNIISPLATC M04AA03

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

Identification

ManufacturerNorthStar RxLLC

CountryUS (United States)

ATC codeM04AA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1671406001
30 TABLET, FILM COATED in 1 BOTTLE (16714-060-01)

Annotations

UNII (FDA Substance ID)

101V0R1N2E

FEBUXOSTAT

RxCUI 73689

Orange Book

A205467

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": "16714-060_0284b7a5-7a1f-4e37-9883-b7bdba68c42b",
  "productndc": "16714-060",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205467",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Jul 1, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Jul 1, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FEBUXOSTAT",
  "proprietary_name": "Febuxostat",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205467",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Febuxostat",
  "start_marketing_date": "20210126",
  "active_numerator_strength": "80"
}

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