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United States · US · US:72205-029_acca11ed-dee8-41ea-bbfb-665392250dba

Febuxostat

Orange BookUNIISPLATC M04AA03

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

Identification

ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeM04AA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7220502930
    30 TABLET, FILM COATED in 1 BOTTLE (72205-029-30)
  • ndc11
    7220502990
    90 TABLET, FILM COATED in 1 BOTTLE (72205-029-90)
  • ndc11
    7220502991
    100 TABLET, FILM COATED in 1 BOTTLE (72205-029-91)
  • ndc11
    7220502999
    1000 TABLET, FILM COATED in 1 BOTTLE (72205-029-99)

Annotations

UNII (FDA Substance ID)
101V0R1N2E
FEBUXOSTAT
RxCUI 73689
Orange Book
A210461
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": "72205-029_acca11ed-dee8-41ea-bbfb-665392250dba",
  "productndc": "72205-029",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210461",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Dec 30, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Dec 30, 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": "ANDA210461",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Febuxostat",
  "start_marketing_date": "20191230",
  "active_numerator_strength": "80"
}

Related drugs

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