Fenofibrate

Orange BookUNIISPLATC C10AB05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeC10AB05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5965120301
100 CAPSULE in 1 BOTTLE (59651-203-01)

Annotations

UNII (FDA Substance ID)

U202363UOS

FENOFIBRATE

RxCUI 221100

Orange Book

A212232

ABABAB

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": "59651-203_05957860-eab3-4172-9877-455540d0c922",
  "productndc": "59651-203",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "212232",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "67MG",
        "product_no": "001",
        "approval_date": "Sep 20, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "134MG",
        "product_no": "002",
        "approval_date": "Sep 20, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Sep 20, 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": "ANDA212232",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fenofibrate",
  "start_marketing_date": "20210920",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code C10AB05.

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