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United States · US · US:71335-2016_72a68150-905a-4ecd-a439-1cb925684873

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
    7133520161
    30 TABLET, FILM COATED in 1 BOTTLE (71335-2016-1)
  • ndc11
    7133520162
    90 TABLET, FILM COATED in 1 BOTTLE (71335-2016-2)
  • ndc11
    7133520163
    28 TABLET, FILM COATED in 1 BOTTLE (71335-2016-3)

Annotations

UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A202856
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": "71335-2016_72a68150-905a-4ecd-a439-1cb925684873",
  "productndc": "71335-2016",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202856",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "48MG",
        "product_no": "001",
        "approval_date": "Dec 7, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "145MG",
        "product_no": "002",
        "approval_date": "Dec 7, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRATE",
  "proprietary_name": "Fenofibrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202856",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fenofibrate",
  "start_marketing_date": "20130514",
  "active_numerator_strength": "145"
}

Related drugs

Other records sharing ATC code C10AB05.

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