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United States · US · US:0115-1554_72e2c9bb-63d6-4a3b-bee1-52a18e95bf0a

Fenofibric Acid

Orange BookUNIISPLATC C10AB

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

Identification

ManufacturerAmneal Pharmaceuticals of New York LLC
CountryUS (United States)
ATC codeC10AB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0115155410
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1554-10)

Annotations

UNII (FDA Substance ID)
BGF9MN2HU1
FENOFIBRIC ACID
RxCUI 24852
Orange Book
N022224
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": "0115-1554_72e2c9bb-63d6-4a3b-bee1-52a18e95bf0a",
  "productndc": "0115-1554",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "022224",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 45MG FENOFIBRIC ACID",
        "product_no": "001",
        "approval_date": "Dec 15, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 135MG FENOFIBRIC ACID",
        "product_no": "002",
        "approval_date": "Dec 15, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRIC ACID",
  "proprietary_name": "Fenofibric Acid",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022224",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Fenofibric Acid",
  "start_marketing_date": "20160912",
  "active_numerator_strength": "45"
}

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