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United States · US · US:55111-797_25711455-9482-c211-793c-6d09539f1c09

Febuxostat

Orange BookUNIISPLATC M04AA03

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

Identification

ManufacturerDR REDDY'S LABORATORIES LIMITED
CountryUS (United States)
ATC codeM04AA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    5511179701
    100 TABLET in 1 BOTTLE (55111-797-01)
  • ndc11
    5511179705
    500 TABLET in 1 BOTTLE (55111-797-05)
  • ndc11
    5511179730
    30 TABLET in 1 BOTTLE (55111-797-30)
  • ndc11
    5511179790
    90 TABLET in 1 BOTTLE (55111-797-90)

Annotations

UNII (FDA Substance ID)
101V0R1N2E
FEBUXOSTAT
RxCUI 73689
Orange Book
A205374
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": "55111-797_25711455-9482-c211-793c-6d09539f1c09",
  "productndc": "55111-797",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205374",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Oct 22, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG",
        "product_no": "002",
        "approval_date": "Oct 22, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FEBUXOSTAT",
  "proprietary_name": "Febuxostat",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205374",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Febuxostat",
  "start_marketing_date": "20201125",
  "active_numerator_strength": "80"
}

Related drugs

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