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United States · US · US:46708-245_4f5277a1-2983-4cf9-b589-714d5fc586c0

Fenofibric Acid

Orange BookUNIISPLATC C10AB

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

Identification

ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeC10AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4670824530
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-30)
  • ndc11
    4670824590
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-90)
  • ndc11
    4670824591
    1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-91)

Annotations

UNII (FDA Substance ID)
BGF9MN2HU1
FENOFIBRIC ACID
RxCUI 24852
Orange Book
A208705
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "BGF9MN2HU1",
    "rxcui": "24852",
    "inchikey": "MQOBSOSZFYZQOK-UHFFFAOYSA-N",
    "display_name": "FENOFIBRIC ACID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "369b3e55-2c05-d879-fe7e-91296c529ae9": {
      "match": "brand_token",
      "title": "FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]",
      "spl_version": "89",
      "published_date": "2025-11-19"
    }
  },
  "productid": "46708-245_4f5277a1-2983-4cf9-b589-714d5fc586c0",
  "productndc": "46708-245",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "208705",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 45MG FENOFIBRIC ACID",
        "product_no": "001",
        "approval_date": "May 12, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 135MG FENOFIBRIC ACID",
        "product_no": "002",
        "approval_date": "May 12, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRIC ACID",
  "proprietary_name": "Fenofibric Acid",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208705",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fenofibric Acid",
  "start_marketing_date": "20170518",
  "active_numerator_strength": "135"
}

Related drugs

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