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United States · US · US:59651-217_21dc5a32-9e47-415c-8b55-f97c5e7b15e1

FENOFIBRIC ACID

Orange BookUNIISPLATC C10AB

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

Identification

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

Packs · 1

  • ndc11
    5965121790
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-217-90)

Annotations

UNII (FDA Substance ID)
BGF9MN2HU1
FENOFIBRIC ACID
RxCUI 24852
Orange Book
A212598
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": "59651-217_21dc5a32-9e47-415c-8b55-f97c5e7b15e1",
  "productndc": "59651-217",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "212598",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 45MG FENOFIBRIC ACID",
        "product_no": "001",
        "approval_date": "Jul 25, 2019"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 135MG FENOFIBRIC ACID",
        "product_no": "002",
        "approval_date": "Jul 25, 2019"
      }
    ],
    "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": "ANDA212598",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FENOFIBRIC ACID",
  "start_marketing_date": "20190725",
  "active_numerator_strength": "135"
}

Related drugs

Other records sharing ATC code C10AB.

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