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United States · US · US:27241-117_698b59bf-d672-4ea4-8f3d-dcaee5329a39

fenofibrate

Orange BookUNIISPLATC C10AB05

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

Identification

ManufacturerAjanta Pharma USA Inc.
CountryUS (United States)
ATC codeC10AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2724111703
    90 TABLET in 1 BOTTLE (27241-117-03)
  • ndc11
    2724111705
    500 TABLET in 1 BOTTLE (27241-117-05)

Annotations

UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A210138
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "U202363UOS",
    "rxcui": "221100",
    "inchikey": "YMTINGFKWWXKFG-UHFFFAOYSA-N",
    "display_name": "FENOFIBRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3a69e15a-eda6-4a6e-8934-6881e4370521": {
      "match": "brand_token",
      "title": "FENOFIBRATE CAPSULE [ANI PHARMACEUTICALS, INC.]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "27241-117_698b59bf-d672-4ea4-8f3d-dcaee5329a39",
  "productndc": "27241-117",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210138",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "54MG",
        "product_no": "001",
        "approval_date": "Jul 23, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "160MG",
        "product_no": "002",
        "approval_date": "Jul 23, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRATE",
  "proprietary_name": "fenofibrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210138",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fenofibrate",
  "start_marketing_date": "20180720",
  "active_numerator_strength": "160"
}

Related drugs

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