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United States · US · US:62135-894_459be037-d59a-9ee0-e063-6394a90a3b5e

fenofibrate

Orange BookUNIISPLATC C10AB05

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

Identification

ManufacturerChartwell RX, LLC.
CountryUS (United States)
ATC codeC10AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6213589490
    90 CAPSULE in 1 BOTTLE (62135-894-90)

Annotations

UNII (FDA Substance ID)
U202363UOS
FENOFIBRATE
RxCUI 221100
Orange Book
A211407
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": "62135-894_459be037-d59a-9ee0-e063-6394a90a3b5e",
  "productndc": "62135-894",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211407",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "67MG",
        "product_no": "001",
        "approval_date": "Jan 31, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "134MG",
        "product_no": "002",
        "approval_date": "Jan 31, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Jan 31, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FENOFIBRATE",
  "proprietary_name": "fenofibrate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211407",
  "marketing_category": "ANDA",
  "nonproprietary_name": "fenofibrate",
  "start_marketing_date": "20240131",
  "active_numerator_strength": "134"
}

Related drugs

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