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United States · US · US:71335-2654_d4158878-3666-47ec-b6f2-680db3dadd9a

Fenofibrate

Orange BookUNIISPLATC C10AB05

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeC10AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7133526541
    30 TABLET, FILM COATED in 1 BOTTLE (71335-2654-1)
  • ndc11
    7133526542
    90 TABLET, FILM COATED in 1 BOTTLE (71335-2654-2)
  • ndc11
    7133526543
    28 TABLET, FILM COATED in 1 BOTTLE (71335-2654-3)

Annotations

UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A204598
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": "71335-2654_d4158878-3666-47ec-b6f2-680db3dadd9a",
  "productndc": "71335-2654",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204598",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "48MG",
        "product_no": "001",
        "approval_date": "Jul 12, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "145MG",
        "product_no": "002",
        "approval_date": "Jul 12, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRATE",
  "proprietary_name": "Fenofibrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204598",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fenofibrate",
  "start_marketing_date": "20160714",
  "active_numerator_strength": "48"
}

Related drugs

Other records sharing ATC code C10AB05.

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