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United States · US · US:51407-005_4f83c23c-def0-5944-e063-6294a90a8224

Fenofibrate

Orange BookUNIISPLATC C10AB05

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

Identification

ManufacturerGolden State Medical Supply, Inc.
CountryUS (United States)
ATC codeC10AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5140700590
    90 TABLET, FILM COATED in 1 BOTTLE (51407-005-90)

Annotations

UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A208476
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": "51407-005_4f83c23c-def0-5944-e063-6294a90a8224",
  "productndc": "51407-005",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208476",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "48MG",
        "product_no": "001",
        "approval_date": "Feb 10, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "145MG",
        "product_no": "002",
        "approval_date": "Feb 10, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRATE",
  "proprietary_name": "Fenofibrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA208476",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fenofibrate",
  "start_marketing_date": "20210210",
  "active_numerator_strength": "48"
}

Related drugs

Other records sharing ATC code C10AB05.

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