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United States · US · US:27241-120_2dffe879-0f18-4961-b1a9-0d69565a04a6

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
    2724112004
    100 CAPSULE in 1 BOTTLE (27241-120-04)
  • ndc11
    2724112005
    500 CAPSULE in 1 BOTTLE (27241-120-05)

Annotations

UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A210705
ABABAB
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": "27241-120_2dffe879-0f18-4961-b1a9-0d69565a04a6",
  "productndc": "27241-120",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "210705",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "67MG",
        "product_no": "001",
        "approval_date": "Sep 10, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "134MG",
        "product_no": "002",
        "approval_date": "Sep 10, 2018"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Sep 10, 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": "ANDA210705",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fenofibrate",
  "start_marketing_date": "20180910",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code C10AB05.

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